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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multifocal Motor Neuropathy

    Summary
    EudraCT number
    2009-013841-27
    Trial protocol
    DK  
    Global end of trial date
    11 Aug 2011

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Mar 2016
    First version publication date
    05 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    160604
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00666263
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Baxalta Innovations GmbH
    Sponsor organisation address
    Industriestrasse 67, Vienna, Austria, 1221
    Public contact
    Clinical Trial Registries and Results Disclosure, Baxalta Innovations GmbH, ClinicalTrialsDisclosure@baxalta.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, Baxalta Innovations GmbH, ClinicalTrialsDisclosure@baxalta.com
    Sponsor organisation name
    Baxalta US Inc.
    Sponsor organisation address
    One Baxter Way, Westlake Village, United States, CA 91362
    Public contact
    Clinical Trial Registries and Results Disclosure, Baxalta US Inc., ClinicalTrialsDisclosure@baxalta.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, Baxalta US Inc., ClinicalTrialsDisclosure@baxalta.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Aug 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Aug 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of the current study was to evaluate the efficacy (effect on grip strength and disability) and safety/tolerability of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) in subjects with Multifocal Motor Neuropathy (MMN).
    Protection of trial subjects
    This study was conducted in accordance with this protocol, the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice, Title 21 of the US Code of Federal Regulations and the European Directive.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    22 Aug 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 14
    Country: Number of subjects enrolled
    Denmark: 2
    Country: Number of subjects enrolled
    United States: 28
    Worldwide total number of subjects
    44
    EEA total number of subjects
    2
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    39
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Recruitment was conducted in the U.S., Canada, and Europe at 17 study sites. The first subject was enrolled in August 2008.

    Pre-assignment
    Screening details
    Fifty unique potential subjects were enrolled (signed informed consent) at clinical study sites in North America and Europe. Six were screen failures. Therefore, 44 subjects were randomized and treated.

    Pre-assignment period milestones
    Number of subjects started
    50 [1]
    Number of subjects completed
    44

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Screen Failure: 6
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The worldwide number of subjects enrolled only included subjects treated with study product (N=44) as per definition of enrolled in EudraCT (Enrolled=Treated). The number of subjects reported in the pre-assignment period includes all subjects enrolled in the study i.e. signed informed consent (N=50).
    Period 1
    Period 1 title
    Study Part 1 (Stabilization Phase 1)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Each of the following 5 study parts was 12 weeks. 1: Open-label phase of treatment/stabilization with IGIV, 10% (Stabilization Phase 1); 2: IGIV, 10% or placebo (double-blind treatment cross-over period 1); 3: Open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2); 4: IGIV, 10% or placebo (double-blind treatment cross-over period 2); 5: Open-label phase of treatment/stabilization with IGIV, 10% (Stabilization Phase 3). Placebo was 0.25% human albumin.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Arm 1: IGIV, 10% then Placebo (During Cross-Over Periods)
    Arm description
    Study Part 1: Open-label phase of treatment/stabilization on Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for 12 weeks (Stabilization Phase 1). Includes all subjects who received IGIV, 10% during Study Part 2 (double-blind treatment cross-over Period 1) and Placebo during Study Part 4 (double-blind treatment cross-over Period 2).
    Arm type
    Experimental

    Investigational medicinal product name
    IGIV, 10%
    Investigational medicinal product code
    Other name
    GAMMARGARD LIQUID (US, Canada), KIOVIG (EU)
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Immune globulin intravenous (Human), 10% (IGIV, 10%) solution consists of 1 vial of a liquid solution containing 100 mg/mL protein, of which at least 98% is Immunoglobulin (IgG). Subjects were dosed intravenously at increasing rates of infusion starting at 0.5 mL/kg body weight/hour (BM/h) and increasing to a maximum rate of 5.0 mL/kg BW/h. Alternatively Institutional Standardized Infusion Rate Protocols may be used. Rate of infusion could be adjusted at the investigator's discretion.

    Arm title
    Arm 2: Placebo then IGIV, 10% (During Cross-Over Periods)
    Arm description
    Study Part 1: Open-label phase of treatment/stabilization on Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for 12 weeks (Stabilization Phase 1). Includes all subjects who received Placebo during Study Part 2 (double-blind treatment cross-over Period 1) and IGIV, 10% during Study Part 4 (double-blind treatment cross-over Period 2).
    Arm type
    Experimental

    Investigational medicinal product name
    IGIV, 10%
    Investigational medicinal product code
    Other name
    GAMMARGARD LIQUID (US, Canada), KIOVIG (EU)
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Immune globulin intravenous (Human), 10% (IGIV, 10%) solution consists of 1 vial of a liquid solution containing 100 mg/mL protein, of which at least 98% is Immunoglobulin (IgG). Subjects were dosed intravenously at increasing rates of infusion starting at 0.5 mL/kg body weight/hour (BM/h) and increasing to a maximum rate of 5.0 mL/kg BW/h. Alternatively Institutional Standardized Infusion Rate Protocols may be used. Rate of infusion could be adjusted at the investigator's discretion.

    Number of subjects in period 1
    Arm 1: IGIV, 10% then Placebo (During Cross-Over Periods) Arm 2: Placebo then IGIV, 10% (During Cross-Over Periods)
    Started
    22
    22
    Completed
    22
    21
    Not completed
    0
    1
         Adverse event, non-fatal
             -
             1
    Period 2
    Period 2 title
    Study Part 2 (Cross-over Period 1)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Subject
    Blinding implementation details
    Each of the following 5 study parts was 12 weeks. 1: Open-label phase of treatment/stabilization with IGIV, 10% (Stabilization Phase 1); 2: IGIV, 10% or placebo (double-blind treatment cross-over period 1); 3: Open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2); 4: IGIV, 10% or placebo (double-blind treatment cross-over period 2); 5: Open-label phase of treatment/stabilization with IGIV, 10% (Stabilization Phase 3). Placebo was 0.25% human albumin.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Arm 1: IGIV, 10% then Placebo (During Cross-Over Periods)
    Arm description
    Study Part 2: double-blind treatment cross-over period 1 for 12 weeks. Includes all subjects who received Immune Globulin Intravenous (Human), 10% (IGIV, 10%) during this study period.
    Arm type
    Experimental

    Investigational medicinal product name
    IGIV, 10%
    Investigational medicinal product code
    Other name
    GAMMARGARD LIQUID (US, Canada), KIOVIG (EU)
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Immune globulin intravenous (Human), 10% (IGIV, 10%) solution consists of 1 vial of a liquid solution containing 100 mg/mL protein, of which at least 98% is Immunoglobulin (IgG). Subjects were dosed intravenously at increasing rates of infusion starting at 0.5 mL/kg body weight/hour (BM/h) and increasing to a maximum rate of 5.0 mL/kg BW/h. Alternatively Institutional Standardized Infusion Rate Protocols may be used. Rate of infusion could be adjusted at the investigator's discretion.

    Investigational medicinal product name
    Placebo - 0.25% Albumin (Human) Solution
    Investigational medicinal product code
    Other name
    BUMINATE or Human Albumin 200 g/L Baxter Solution for Infusion
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used. Placebo administred at the same volume as IGIV, 10% that the subject received before being randomized.

    Arm title
    Arm 2: Placebo then IGIV, 10% (During Cross-Over Periods)
    Arm description
    Study Part 2: double-blind treatment cross-over period 1 for 12 weeks. Includes all subjects who received Placebo during this study period.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo - 0.25% Albumin (Human) Solution
    Investigational medicinal product code
    Other name
    BUMINATE or Human Albumin 200 g/L Baxter Solution for Infusion
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used. Placebo administred at the same volume as IGIV, 10% that the subject received before being randomized.

    Investigational medicinal product name
    IGIV, 10%
    Investigational medicinal product code
    Other name
    GAMMARGARD LIQUID (US, Canada), KIOVIG (EU)
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Immune globulin intravenous (Human), 10% (IGIV, 10%) solution consists of 1 vial of a liquid solution containing 100 mg/mL protein, of which at least 98% is Immunoglobulin (IgG). Subjects were dosed intravenously at increasing rates of infusion starting at 0.5 mL/kg body weight/hour (BM/h) and increasing to a maximum rate of 5.0 mL/kg BW/h. Alternatively Institutional Standardized Infusion Rate Protocols may be used. Rate of infusion could be adjusted at the investigator's discretion.

    Number of subjects in period 2
    Arm 1: IGIV, 10% then Placebo (During Cross-Over Periods) Arm 2: Placebo then IGIV, 10% (During Cross-Over Periods)
    Started
    22
    21
    Completed
    22
    21
    Period 3
    Period 3 title
    Study Part 3 (Stabilization Phase 2)
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Each of the following 5 study parts was 12 weeks. 1: Open-label phase of treatment/stabilization with IGIV, 10% (Stabilization Phase 1); 2: IGIV, 10% or placebo (double-blind treatment cross-over period 1); 3: Open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2); 4: IGIV, 10% or placebo (double-blind treatment cross-over period 2); 5: Open-label phase of treatment/stabilization with IGIV, 10% (Stabilization Phase 3). Placebo was 0.25% human albumin.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Arm 1: IGIV, 10% then Placebo (During Cross-Over Periods
    Arm description
    Study Part 3: Stabilzation Phase 2. Between the two double-blind treatment cross-over periods, subjects received open-label treatment/stabilization with Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for 12 weeks. Includes all subjects who received IGIV, 10% during Study Part 2 (double-blind treatment cross-over Period 1) and Placebo during Study Part 4 (double-blind treatment cross-over Period 2).
    Arm type
    Experimental

    Investigational medicinal product name
    IGIV, 10%
    Investigational medicinal product code
    Other name
    GAMMARGARD LIQUID (US, Canada), KIOVIG (EU)
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Immune globulin intravenous (Human), 10% (IGIV, 10%) solution consists of 1 vial of a liquid solution containing 100 mg/mL protein, of which at least 98% is Immunoglobulin (IgG). Subjects were dosed intravenously at increasing rates of infusion starting at 0.5 mL/kg body weight/hour (BM/h) and increasing to a maximum rate of 5.0 mL/kg BW/h. Alternatively Institutional Standardized Infusion Rate Protocols may be used. Rate of infusion could be adjusted at the investigator's discretion.

    Investigational medicinal product name
    Placebo - 0.25% Albumin (Human) Solution
    Investigational medicinal product code
    Other name
    BUMINATE or Human Albumin 200 g/L Baxter Solution for Infusion
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used. Placebo administred at the same volume as IGIV, 10% that the subject received before being randomized.

    Arm title
    Arm 2: Placebo then IGIV, 10% (During Cross-Over Periods)
    Arm description
    Study Part 3: Stabilzation Phase 2. Between the two double-blind treatment cross-over periods, subjects received open-label treatment/stabilization with Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for 12 weeks. Includes all subjects who received Placebo during Study Part 2 (double-blind treatment cross-over Period 1) and IGIV, 10% during Study Part 4 (double-blind treatment cross-over Period 2).
    Arm type
    Experimental

    Investigational medicinal product name
    IGIV, 10%
    Investigational medicinal product code
    Other name
    GAMMARGARD LIQUID (US, Canada), KIOVIG (EU)
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Immune globulin intravenous (Human), 10% (IGIV, 10%) solution consists of 1 vial of a liquid solution containing 100 mg/mL protein, of which at least 98% is Immunoglobulin (IgG). Subjects were dosed intravenously at increasing rates of infusion starting at 0.5 mL/kg body weight/hour (BM/h) and increasing to a maximum rate of 5.0 mL/kg BW/h. Alternatively Institutional Standardized Infusion Rate Protocols may be used. Rate of infusion could be adjusted at the investigator's discretion.

    Investigational medicinal product name
    Placebo - 0.25% Albumin (Human) Solution
    Investigational medicinal product code
    Other name
    BUMINATE or Human Albumin 200 g/L Baxter Solution for Infusion
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used. Placebo administred at the same volume as IGIV, 10% that the subject received before being randomized.

    Number of subjects in period 3
    Arm 1: IGIV, 10% then Placebo (During Cross-Over Periods Arm 2: Placebo then IGIV, 10% (During Cross-Over Periods)
    Started
    22
    21
    Completed
    22
    21
    Period 4
    Period 4 title
    Study Part 4 (Cross-over Period 2)
    Is this the baseline period?
    No
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    Each of the following 5 study parts was 12 weeks. 1: Open-label phase of treatment/stabilization with IGIV, 10% (Stabilization Phase 1); 2: IGIV, 10% or placebo (double-blind treatment cross-over period 1); 3: Open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2); 4: IGIV, 10% or placebo (double-blind treatment cross-over period 2); 5: Open-label phase of treatment/stabilization with IGIV, 10% (Stabilization Phase 3). Placebo was 0.25% human albumin.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Arm 1: IGIV, 10% then Placebo (During Cross-Over Periods
    Arm description
    Study Part 4: double-blind treatment cross-over period 2 for 12 weeks. Includes all subjects who received Placebo during this study period.
    Arm type
    Experimental

    Investigational medicinal product name
    IGIV, 10%
    Investigational medicinal product code
    Other name
    GAMMARGARD LIQUID (US, Canada), KIOVIG (EU)
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Immune globulin intravenous (Human), 10% (IGIV, 10%) solution consists of 1 vial of a liquid solution containing 100 mg/mL protein, of which at least 98% is Immunoglobulin (IgG). Subjects were dosed intravenously at increasing rates of infusion starting at 0.5 mL/kg body weight/hour (BM/h) and increasing to a maximum rate of 5.0 mL/kg BW/h. Alternatively Institutional Standardized Infusion Rate Protocols may be used. Rate of infusion could be adjusted at the investigator's discretion.

    Investigational medicinal product name
    Placebo - 0.25% Albumin (Human) Solution
    Investigational medicinal product code
    Other name
    BUMINATE or Human Albumin 200 g/L Baxter Solution for Infusion
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used. Placebo administred at the same volume as IGIV, 10% that the subject received before being randomized.

    Arm title
    Arm 2: Placebo then IGIV, 10% (During Cross-Over Periods)
    Arm description
    Study Part 4: double-blind treatment cross-over period 2 for 12 weeks. Includes all subjects who received Immune Globulin Intravenous (Human), 10% (IGIV, 10%) during this study period.
    Arm type
    Experimental

    Investigational medicinal product name
    IGIV, 10%
    Investigational medicinal product code
    Other name
    GAMMARGARD LIQUID (US, Canada), KIOVIG (EU)
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Immune globulin intravenous (Human), 10% (IGIV, 10%) solution consists of 1 vial of a liquid solution containing 100 mg/mL protein, of which at least 98% is Immunoglobulin (IgG). Subjects were dosed intravenously at increasing rates of infusion starting at 0.5 mL/kg body weight/hour (BM/h) and increasing to a maximum rate of 5.0 mL/kg BW/h. Alternatively Institutional Standardized Infusion Rate Protocols may be used. Rate of infusion could be adjusted at the investigator's discretion.

    Investigational medicinal product name
    Placebo - 0.25% Albumin (Human) Solution
    Investigational medicinal product code
    Other name
    BUMINATE or Human Albumin 200 g/L Baxter Solution for Infusion
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used. Placebo administred at the same volume as IGIV, 10% that the subject received before being randomized.

    Number of subjects in period 4
    Arm 1: IGIV, 10% then Placebo (During Cross-Over Periods Arm 2: Placebo then IGIV, 10% (During Cross-Over Periods)
    Started
    22
    21
    Completed
    21
    21
    Not completed
    1
    0
         Adverse event, non-fatal
             1
             -
    Period 5
    Period 5 title
    Study Part 5 (Stabilization Phase 3)
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Each of the following 5 study parts was 12 weeks. 1: Open-label phase of treatment/stabilization with IGIV, 10% (Stabilization Phase 1); 2: IGIV, 10% or placebo (double-blind treatment cross-over period 1); 3: Open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2); 4: IGIV, 10% or placebo (double-blind treatment cross-over period 2); 5: Open-label phase of treatment/stabilization with IGIV, 10% (Stabilization Phase 3). Placebo was 0.25% human albumin.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Arm 1: IGIV, 10% then Placebo (During Cross-Over Periods
    Arm description
    Study Part 5: Subjects received open-label treatment/stabilization with Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for 12 weeks (Stabilization Phase 3). Includes all subjects who received IGIV, 10% during Study Part 2 (double-blind treatment cross-over Period 1) and Placebo during Study Part 4 (double-blind treatment cross-over Period 2).
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo - 0.25% Albumin (Human) Solution
    Investigational medicinal product code
    Other name
    BUMINATE or Human Albumin 200 g/L Baxter Solution for Infusion
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used. Placebo administred at the same volume as IGIV, 10% that the subject received before being randomized.

    Investigational medicinal product name
    IGIV, 10%
    Investigational medicinal product code
    Other name
    GAMMARGARD LIQUID (US, Canada), KIOVIG (EU)
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Immune globulin intravenous (Human), 10% (IGIV, 10%) solution consists of 1 vial of a liquid solution containing 100 mg/mL protein, of which at least 98% is Immunoglobulin (IgG). Subjects were dosed intravenously at increasing rates of infusion starting at 0.5 mL/kg body weight/hour (BM/h) and increasing to a maximum rate of 5.0 mL/kg BW/h. Alternatively Institutional Standardized Infusion Rate Protocols may be used. Rate of infusion could be adjusted at the investigator's discretion.

    Arm title
    Arm 2: Placebo then IGIV, 10% (During Cross-Over Periods)
    Arm description
    Study Part 5: Subjects received open-label treatment/stabilization with Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for 12 weeks (Stabilization Phase 3). Includes all subjects who received Placebo during Study Part 2 (double-blind treatment cross-over Period 1) and IGIV, 10% during Study Part 4 (double-blind treatment cross-over Period 2).
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo - 0.25% Albumin (Human) Solution
    Investigational medicinal product code
    Other name
    BUMINATE or Human Albumin 200 g/L Baxter Solution for Infusion
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used. Placebo administred at the same volume as IGIV, 10% that the subject received before being randomized.

    Investigational medicinal product name
    IGIV, 10%
    Investigational medicinal product code
    Other name
    GAMMARGARD LIQUID (US, Canada), KIOVIG (EU)
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Immune globulin intravenous (Human), 10% (IGIV, 10%) solution consists of 1 vial of a liquid solution containing 100 mg/mL protein, of which at least 98% is Immunoglobulin (IgG). Subjects were dosed intravenously at increasing rates of infusion starting at 0.5 mL/kg body weight/hour (BM/h) and increasing to a maximum rate of 5.0 mL/kg BW/h. Alternatively Institutional Standardized Infusion Rate Protocols may be used. Rate of infusion could be adjusted at the investigator's discretion.

    Number of subjects in period 5
    Arm 1: IGIV, 10% then Placebo (During Cross-Over Periods Arm 2: Placebo then IGIV, 10% (During Cross-Over Periods)
    Started
    21
    21
    Completed
    21
    20
    Not completed
    0
    1
         Consent withdrawn by subject
             -
             1
    Period 6
    Period 6 title
    End of Study Visit
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Each of the following 5 study parts was 12 weeks. 1: Open-label phase of treatment/stabilization with IGIV, 10% (Stabilization Phase 1); 2: IGIV, 10% or placebo (double-blind treatment cross-over period 1); 3: Open-label treatment/stabilization with IGIV, 10% (Stabilization Phase 2); 4: IGIV, 10% or placebo (double-blind treatment cross-over period 2); 5: Open-label phase of treatment/stabilization with IGIV, 10% (Stabilization Phase 3). Placebo was 0.25% human albumin.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    Arm 1: IGIV, 10% then Placebo (During Cross-Over Periods
    Arm description
    End of Study Visit conducted on 21 randomized subjects regardless of participation in Study Parts (except for one subject who withdrew and did not attend End of Study Visit).
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo - 0.25% Albumin (Human) Solution
    Investigational medicinal product code
    Other name
    BUMINATE or Human Albumin 200 g/L Baxter Solution for Infusion
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used. Placebo administred at the same volume as IGIV, 10% that the subject received before being randomized.

    Investigational medicinal product name
    IGIV, 10%
    Investigational medicinal product code
    Other name
    GAMMARGARD LIQUID (US, Canada), KIOVIG (EU)
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Immune globulin intravenous (Human), 10% (IGIV, 10%) solution consists of 1 vial of a liquid solution containing 100 mg/mL protein, of which at least 98% is Immunoglobulin (IgG). Subjects were dosed intravenously at increasing rates of infusion starting at 0.5 mL/kg body weight/hour (BM/h) and increasing to a maximum rate of 5.0 mL/kg BW/h. Alternatively Institutional Standardized Infusion Rate Protocols may be used. Rate of infusion could be adjusted at the investigator's discretion.

    Arm title
    Arm 2: Placebo then IGIV, 10% (During Cross-Over Periods)
    Arm description
    End of Study Visit done on all 22 randomized subjects regardless of participation in Study Parts.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo - 0.25% Albumin (Human) Solution
    Investigational medicinal product code
    Other name
    BUMINATE or Human Albumin 200 g/L Baxter Solution for Infusion
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used. Placebo administred at the same volume as IGIV, 10% that the subject received before being randomized.

    Investigational medicinal product name
    IGIV, 10%
    Investigational medicinal product code
    Other name
    GAMMARGARD LIQUID (US, Canada), KIOVIG (EU)
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Immune globulin intravenous (Human), 10% (IGIV, 10%) solution consists of 1 vial of a liquid solution containing 100 mg/mL protein, of which at least 98% is Immunoglobulin (IgG). Subjects were dosed intravenously at increasing rates of infusion starting at 0.5 mL/kg body weight/hour (BM/h) and increasing to a maximum rate of 5.0 mL/kg BW/h. Alternatively Institutional Standardized Infusion Rate Protocols may be used. Rate of infusion could be adjusted at the investigator's discretion.

    Number of subjects in period 6
    Arm 1: IGIV, 10% then Placebo (During Cross-Over Periods Arm 2: Placebo then IGIV, 10% (During Cross-Over Periods)
    Started
    21
    22
    Completed
    21
    22

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Study Part 1 (Stabilization Phase 1)
    Reporting group description
    Study Part 1 (Stabilization Phase 1)

    Reporting group values
    Study Part 1 (Stabilization Phase 1) Total
    Number of subjects
    44
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    51.64 ± 10.25 -
    Gender categorical
    Units: Subjects
        Female
    12 12
        Male
    32 32

    End points

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    End points reporting groups
    Reporting group title
    Arm 1: IGIV, 10% then Placebo (During Cross-Over Periods)
    Reporting group description
    Study Part 1: Open-label phase of treatment/stabilization on Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for 12 weeks (Stabilization Phase 1). Includes all subjects who received IGIV, 10% during Study Part 2 (double-blind treatment cross-over Period 1) and Placebo during Study Part 4 (double-blind treatment cross-over Period 2).

    Reporting group title
    Arm 2: Placebo then IGIV, 10% (During Cross-Over Periods)
    Reporting group description
    Study Part 1: Open-label phase of treatment/stabilization on Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for 12 weeks (Stabilization Phase 1). Includes all subjects who received Placebo during Study Part 2 (double-blind treatment cross-over Period 1) and IGIV, 10% during Study Part 4 (double-blind treatment cross-over Period 2).
    Reporting group title
    Arm 1: IGIV, 10% then Placebo (During Cross-Over Periods)
    Reporting group description
    Study Part 2: double-blind treatment cross-over period 1 for 12 weeks. Includes all subjects who received Immune Globulin Intravenous (Human), 10% (IGIV, 10%) during this study period.

    Reporting group title
    Arm 2: Placebo then IGIV, 10% (During Cross-Over Periods)
    Reporting group description
    Study Part 2: double-blind treatment cross-over period 1 for 12 weeks. Includes all subjects who received Placebo during this study period.
    Reporting group title
    Arm 1: IGIV, 10% then Placebo (During Cross-Over Periods
    Reporting group description
    Study Part 3: Stabilzation Phase 2. Between the two double-blind treatment cross-over periods, subjects received open-label treatment/stabilization with Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for 12 weeks. Includes all subjects who received IGIV, 10% during Study Part 2 (double-blind treatment cross-over Period 1) and Placebo during Study Part 4 (double-blind treatment cross-over Period 2).

    Reporting group title
    Arm 2: Placebo then IGIV, 10% (During Cross-Over Periods)
    Reporting group description
    Study Part 3: Stabilzation Phase 2. Between the two double-blind treatment cross-over periods, subjects received open-label treatment/stabilization with Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for 12 weeks. Includes all subjects who received Placebo during Study Part 2 (double-blind treatment cross-over Period 1) and IGIV, 10% during Study Part 4 (double-blind treatment cross-over Period 2).
    Reporting group title
    Arm 1: IGIV, 10% then Placebo (During Cross-Over Periods
    Reporting group description
    Study Part 4: double-blind treatment cross-over period 2 for 12 weeks. Includes all subjects who received Placebo during this study period.

    Reporting group title
    Arm 2: Placebo then IGIV, 10% (During Cross-Over Periods)
    Reporting group description
    Study Part 4: double-blind treatment cross-over period 2 for 12 weeks. Includes all subjects who received Immune Globulin Intravenous (Human), 10% (IGIV, 10%) during this study period.
    Reporting group title
    Arm 1: IGIV, 10% then Placebo (During Cross-Over Periods
    Reporting group description
    Study Part 5: Subjects received open-label treatment/stabilization with Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for 12 weeks (Stabilization Phase 3). Includes all subjects who received IGIV, 10% during Study Part 2 (double-blind treatment cross-over Period 1) and Placebo during Study Part 4 (double-blind treatment cross-over Period 2).

    Reporting group title
    Arm 2: Placebo then IGIV, 10% (During Cross-Over Periods)
    Reporting group description
    Study Part 5: Subjects received open-label treatment/stabilization with Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for 12 weeks (Stabilization Phase 3). Includes all subjects who received Placebo during Study Part 2 (double-blind treatment cross-over Period 1) and IGIV, 10% during Study Part 4 (double-blind treatment cross-over Period 2).
    Reporting group title
    Arm 1: IGIV, 10% then Placebo (During Cross-Over Periods
    Reporting group description
    End of Study Visit conducted on 21 randomized subjects regardless of participation in Study Parts (except for one subject who withdrew and did not attend End of Study Visit).

    Reporting group title
    Arm 2: Placebo then IGIV, 10% (During Cross-Over Periods)
    Reporting group description
    End of Study Visit done on all 22 randomized subjects regardless of participation in Study Parts.

    Subject analysis set title
    Before Stabilization 1 - All Subjects
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Baseline Measurements

    Subject analysis set title
    End of Stabilization 1 - All Subjects
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Immune Globulin Intravenous (Human), 10% (IGIV, 10%)

    Subject analysis set title
    End of Cross-Over 1 - All Subjects
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Either Immune Globulin Intravenous (Human), 10% (IGIV, 10%) or Placebo

    Subject analysis set title
    End of Stabilization 2 - All Subjects
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Immune Globulin Intravenous (Human), 10% (IGIV, 10%)

    Subject analysis set title
    End of Cross-Over 2 - All Subjects
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Either Immune Globulin Intravenous (Human), 10% (IGIV, 10%) or Placebo. The opposite of the end of Cross-Over 1.

    Subject analysis set title
    End of Stabilization 3 - All Subjects
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Immune Globulin Intravenous (Human), 10% (IGIV, 10%)

    Subject analysis set title
    End of Study - All Subjects
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects returned following last infusion cycle (2,3, or 4 weeks after last infusion during Stabilization 3) for an End-of-Study visit for assessments including; efficacy (eg: grip strength and disability assessments), adverse events collection, physical examination, laboratory and vital signs, collection and review of diaries and other assessments.

    Subject analysis set title
    Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Study Part 1: Open-label phase of treatment/stabilization on Immune Globulin Intravenous (Human), 10% (IGIV, 10%) (Stabilization Phase 1) all subjects; Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1); Study Part 3: Between the two double-blind treatment cross-over periods, subjects received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2); Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2); Study Part 5: Subjects received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3).

    Subject analysis set title
    Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Study Part 1: Open-label phase of treatment/stabilization on Immune Globulin Intravenous (Human), 10% (IGIV, 10%) (Stabilization Phase 1) all subjects; Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1); Study Part 3: Between the two double-blind treatment cross-over periods, subjects received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2); Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2); Study Part 5: Subjects received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3).

    Subject analysis set title
    Arm 2: Placebo Then IGIV, 10% - Placebo Cross-over Period 1
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Study Part 1: Open-label phase of treatment/stabilization on Immune Globulin Intravenous (Human), 10% (IGIV, 10%) (Stabilization Phase 1) all subjects; Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1); Study Part 3: Between the two double-blind treatment cross-over periods, subjects received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2); Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2); Study Part 5: Subjects received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3).

    Subject analysis set title
    Arm 2: Placebo Then IGIV, 10% - IGIV, 10% Cross-over Period 2
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Study Part 1: Open-label phase of treatment/stabilization on Immune Globulin Intravenous (Human), 10% (IGIV, 10%) (Stabilization Phase 1) all subjects; Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1); Study Part 3: Between the two double-blind treatment cross-over periods, subjects received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2); Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2); Study Part 5: Subjects received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3).

    Subject analysis set title
    Deterioration After IGIV, 10% and Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects with deterioration in Guy's Neurological Disability Scale (GNDS) scores after Immune Globulin Intravenous (Human), 10% (IGIV, 10%) and Placebo.

    Subject analysis set title
    Deterioration After Placebo, But Not IGIV, 10%
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects with deterioration in Guy's Neurological Disability Scale (GNDS) scores after Placebo, but not Immune Globulin Intravenous (Human), 10% (IGIV, 10%) .

    Subject analysis set title
    Deterioration After IGIV, 10%, But Not Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects with deterioration in Guy's Neurological Disability Scale (GNDS) scores after Immune Globulin Intravenous (Human), 10% (IGIV, 10%), but not Placebo.

    Subject analysis set title
    No Deterioration After IGIV, 10% or Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects with no deterioration in Guy's Neurological Disability Scale (GNDS) scores after Immune Globulin Intravenous (Human), 10% (IGIV, 10%) or Placebo.

    Subject analysis set title
    Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Study Part 1: Open-label phase of treatment/stabilization on Immune Globulin Intravenous (Human), 10% (IGIV, 10%) (Stabilization Phase 1) all subjects; Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1); Study Part 3: Between the two double-blind treatment cross-over periods, subjects received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2); Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2); Study Part 5: Subjects received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3).

    Subject analysis set title
    Arm 1: IGIV, 10% Then Placebo- Placebo Period
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Study Part 1: Open-label phase of treatment/stabilization on Immune Globulin Intravenous (Human), 10% (IGIV, 10%) (Stabilization Phase 1) all subjects; Study Part 2: IGIV, 10% (double-blind treatment cross-over Period 1); Study Part 3: Between the two double-blind treatment cross-over periods, subjects received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2); Study Part 4: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 2); Study Part 5: Subjects received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3).

    Subject analysis set title
    Arm 2: Placebo Then IGIV, 10%- Placebo Period
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Study Part 1: Open-label phase of treatment/stabilization on Immune Globulin Intravenous (Human), 10% (IGIV, 10%) (Stabilization Phase 1) all subjects; Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1); Study Part 3: Between the two double-blind treatment cross-over periods, subjects received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2); Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2); Study Part 5: Subjects received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3).

    Subject analysis set title
    Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Study Part 1: Open-label phase of treatment/stabilization on Immune Globulin Intravenous (Human), 10% (IGIV, 10%) (Stabilization Phase 1) all subjects; Study Part 2: Placebo (0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used) (double-blind treatment cross-over Period 1); Study Part 3: Between the two double-blind treatment cross-over periods, subjects received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 2); Study Part 4: IGIV, 10% (double-blind treatment cross-over Period 2); Study Part 5: Subjects received open-label treatment/stabilization with IGIV, 10% for 12 weeks (Stabilization Phase 3).

    Subject analysis set title
    Decline Only During IGIV, 10%
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following Immune Globulin Intravenous (Human), 10% (IGIV, 10%), but not after Placebo.

    Subject analysis set title
    Decline Only During Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following the placebo, but not after Immune Globulin Intravenous (Human), 10% (IGIV, 10%).

    Subject analysis set title
    Decline During Both Placebo and IGIV, 10%
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects who experienced a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following Immune Globulin Intravenous (Human), 10% (IGIV, 10%) %, and Placebo.

    Subject analysis set title
    No Decline During Placebo and IGIV, 10%
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects who did not experience a relative decrease in grip strength of ≥30% in the more affected hand relative to baseline following Immune Globulin Intravenous (Human), 10% (IGIV, 10%), and Placebo.

    Subject analysis set title
    Accelerated Switch During IGIV, 10% and Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects who required a switch to open label IGIV, 10% when receiving Immune Globulin Intravenous (Human), 10% (IGIV, 10%), and Placebo.

    Subject analysis set title
    Accelerated Switch During Placebo, But Not IGIV, 10%
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects who required a switch to open label Immune Globulin Intravenous (Human), 10% (IGIV, 10%) when receiving Placebo, but not during IGIV, 10%.

    Subject analysis set title
    Accelerated Switch During IGIV, 10%, But Not Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects who required a switch to open label Immune Globulin Intravenous (Human), 10% (IGIV, 10%) when receiving IGIV, 10%, but not during Placebo.

    Subject analysis set title
    No Accelerated Switch During IGIV, 10% or Placebo
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects who did not require a switch to open label Immune Globulin Intravenous (Human), 10% (IGIV, 10%) when receiving IGIV, 10%, or Placebo.

    Primary: Grip Strength in the More Affected Hand

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    End point title
    Grip Strength in the More Affected Hand [1]
    End point description
    The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. Each grip strength test consisted of 3 maximal repeated contractions (trials). Each subject will perform 2 sessions of grip strength testing. After a 10-minute break, the testing session will be repeated for a total of 6 grip repetitions per hand. Population: Intent To Treat.
    End point type
    Primary
    End point timeframe
    Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive statistics were collected for this endpoint.
    End point values
    Before Stabilization 1 - All Subjects End of Stabilization 1 - All Subjects End of Cross-Over 1 - All Subjects End of Stabilization 2 - All Subjects End of Cross-Over 2 - All Subjects End of Stabilization 3 - All Subjects End of Study - All Subjects
    Number of subjects analysed
    44
    44
    42
    43
    43
    36
    43
    Units: kilograms
    median (inter-quartile range (Q1-Q3))
        IGIV then Placebo (N= 22, 22, 22, 22, 22, 17, 21)
    18.14 (9.3 to 30.43)
    21.68 (14.05 to 30.83)
    19.54 (10.15 to 29.15)
    19.39 (12.75 to 33.25)
    11.28 (5.5 to 25.92)
    17.77 (9.23 to 27.07)
    17.37 (10.8 to 29.03)
        Placebo then IGIV (N= 22, 22, 20, 21, 21, 19, 22)
    13.17 (5.3 to 20.08)
    14.17 (8.08 to 27.47)
    8.38 (4.86 to 17.03)
    14.18 (7.6 to 27.35)
    15.98 (10.73 to 29.65)
    14.28 (9.47 to 28.25)
    14 (7.48 to 24.82)
    No statistical analyses for this end point

    Primary: Mean Relative Change in Grip Strength in the More Affected Hand

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    End point title
    Mean Relative Change in Grip Strength in the More Affected Hand [2]
    End point description
    Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing. Population: Intent To Treat.
    End point type
    Primary
    End point timeframe
    Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Currently unable to enter statistical analysis due to limitation of EudraCT. Statistics are available for these study results in ClinicalTrials.gov (NCT00666263).
    End point values
    Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1 Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2 Arm 2: Placebo Then IGIV, 10% - Placebo Cross-over Period 1 Arm 2: Placebo Then IGIV, 10% - IGIV, 10% Cross-over Period 2
    Number of subjects analysed
    22
    22
    20
    21
    Units: Percent change in grip strength
        arithmetic mean (confidence interval 95%)
    -16.36 (-30.92 to -1.8)
    -30.52 (-43.68 to -17.36)
    -30.11 (-48.41 to -11.81)
    23.86 (-23.11 to 70.83)
    No statistical analyses for this end point

    Primary: Co-Primary Endpoint: Guy's Neurological Disability Score (GNDS) for Upper Limbs

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    End point title
    Co-Primary Endpoint: Guy's Neurological Disability Score (GNDS) for Upper Limbs [3]
    End point description
    GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment. Population: Intent To Treat.
    End point type
    Primary
    End point timeframe
    Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive statistics were collected for this endpoint.
    End point values
    Before Stabilization 1 - All Subjects End of Stabilization 1 - All Subjects End of Cross-Over 1 - All Subjects End of Stabilization 2 - All Subjects End of Cross-Over 2 - All Subjects End of Stabilization 3 - All Subjects End of Study - All Subjects
    Number of subjects analysed
    44
    44
    42
    43
    43
    36
    43
    Units: Scores on a scale
    median (inter-quartile range (Q1-Q3))
        IGIV then Placebo (N= 22, 22, 22, 22, 22, 17, 21)
    2 (2 to 3)
    2 (2 to 2)
    2 (2 to 2)
    2 (2 to 3)
    2.5 (2 to 3)
    2 (2 to 2)
    2 (2 to 2)
        Placebo then IGIV (N= 22, 22, 20, 21, 21, 19, 22)
    2 (2 to 3)
    2 (2 to 3)
    2 (2 to 3)
    2 (1 to 3)
    2 (2 to 3)
    2 (2 to 3)
    2 (2 to 3)
    No statistical analyses for this end point

    Primary: Co-Primary Endpoint: Proportion of Subjects with Deterioration in Guy’s Neurological Disability Score (GNDS)

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    End point title
    Co-Primary Endpoint: Proportion of Subjects with Deterioration in Guy’s Neurological Disability Score (GNDS) [4]
    End point description
    GNDS (based on Sharrack and Hughes, 1999) for the upper limbs were integers 0 to 5, with 0 indicating no impairment. Population: Intent To Treat.
    End point type
    Primary
    End point timeframe
    Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Currently unable to enter statistical analysis due to limitation of EudraCT. Statistics are available for these study results in ClinicalTrials.gov (NCT00666263).
    End point values
    Deterioration After IGIV, 10% and Placebo Deterioration After Placebo, But Not IGIV, 10% Deterioration After IGIV, 10%, But Not Placebo No Deterioration After IGIV, 10% or Placebo
    Number of subjects analysed
    42
    42
    42
    42
    Units: Proportion of subjects
        number (not applicable)
    4.8
    35.7
    11.9
    47.6
    No statistical analyses for this end point

    Primary: Rate of temporally associated adverse events (AEs) per infusion

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    End point title
    Rate of temporally associated adverse events (AEs) per infusion [5]
    End point description
    The total number of all AEs which begin during or within 72 hours of completion of an infusion, irrespective of being related or not related to the study product (IGIV, 10% or Placebo), divided by the total number of infusions, and multiplied by 100. Population: Safety Dataset. Number of infusions [N] analyzed per subject analysis set is as follows: Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period N=104; Arm 1: IGIV, 10% Then Placebo- Placebo Period N=68; Arm 2: Placebo Then IGIV, 10%- Placebo Period N=61; Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period N=138.
    End point type
    Primary
    End point timeframe
    Within 72 hours of completion of an infusion during the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive statistics were collected for this endpoint.
    End point values
    Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period Arm 1: IGIV, 10% Then Placebo- Placebo Period Arm 2: Placebo Then IGIV, 10%- Placebo Period Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period
    Number of subjects analysed
    22
    22
    21
    21
    Units: Percentage of AEs per infusion
        number (not applicable)
    11.5
    13.2
    24.6
    11.6
    No statistical analyses for this end point

    Primary: The percentage of subjects for whom the infusion rate of any infusion was reduced and/or the infusion was interrupted or stopped for any reason

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    End point title
    The percentage of subjects for whom the infusion rate of any infusion was reduced and/or the infusion was interrupted or stopped for any reason [6]
    End point description
    Population: Safety Dataset.
    End point type
    Primary
    End point timeframe
    Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive statistics were collected for this endpoint.
    End point values
    Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period Arm 1: IGIV, 10% Then Placebo- Placebo Period Arm 2: Placebo Then IGIV, 10%- Placebo Period Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period
    Number of subjects analysed
    22
    22
    21
    21
    Units: percentage of subjects
        number (not applicable)
    9.1
    0
    4.8
    4.8
    No statistical analyses for this end point

    Primary: The percentage of infusions for which the infusion rate was reduced and/or the infusion was interrupted or stopped for any reason

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    End point title
    The percentage of infusions for which the infusion rate was reduced and/or the infusion was interrupted or stopped for any reason [7]
    End point description
    Number of infusions [N] analyzed per subject analysis set is as follows: Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period N=104; Arm 1: IGIV, 10% Then Placebo- Placebo Period N=68; Arm 2: Placebo Then IGIV, 10%- Placebo Period N=61; Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period N=138. Population: Safety Dataset.
    End point type
    Primary
    End point timeframe
    Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive statistics were collected for this endpoint.
    End point values
    Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period Arm 1: IGIV, 10% Then Placebo- Placebo Period Arm 2: Placebo Then IGIV, 10%- Placebo Period Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period
    Number of subjects analysed
    22
    22
    21
    21
    Units: percentage of infusions
        number (not applicable)
    2.9
    0
    1.6
    0.7
    No statistical analyses for this end point

    Primary: The percentage of subjects reporting one or more moderate or severe AEs that began during infusion or within 72 hours of completion of an infusion

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    End point title
    The percentage of subjects reporting one or more moderate or severe AEs that began during infusion or within 72 hours of completion of an infusion [8]
    End point description
    Population: Safety Dataset.
    End point type
    Primary
    End point timeframe
    Within 72 hours of completion of an infusion during the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Per protocol, only descriptive statistics were collected for this endpoint.
    End point values
    Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period Arm 1: IGIV, 10% Then Placebo- Placebo Period Arm 2: Placebo Then IGIV, 10%- Placebo Period Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period
    Number of subjects analysed
    22
    22
    21
    21
    Units: percentage of subjects
        number (not applicable)
    4.5
    27.3
    19
    4.8
    No statistical analyses for this end point

    Secondary: Percentage of subjects with at least a 30% decline in relative grip strength in the more affected hand (measured using a DynEx digital dynamometer)

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    End point title
    Percentage of subjects with at least a 30% decline in relative grip strength in the more affected hand (measured using a DynEx digital dynamometer)
    End point description
    Relative grip strength change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing. Population: Intent to Treat.
    End point type
    Secondary
    End point timeframe
    Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
    End point values
    Decline Only During IGIV, 10% Decline Only During Placebo Decline During Both Placebo and IGIV, 10% No Decline During Placebo and IGIV, 10%
    Number of subjects analysed
    42
    42
    42
    42
    Units: Percentage of subjects
        number (not applicable)
    4.8
    42.9
    4.8
    47.6
    No statistical analyses for this end point

    Secondary: Grip Strength in the Less Affected Hand

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    End point title
    Grip Strength in the Less Affected Hand
    End point description
    The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. Each grip strength test consisted of 3 maximal repeated contractions (trials). Each subject will perform 2 sessions of grip strength testing. After a 10-minute break, the testing session will be repeated for a total of 6 grip repetitions per hand. Population: Intent to Treat.
    End point type
    Secondary
    End point timeframe
    Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
    End point values
    Before Stabilization 1 - All Subjects End of Stabilization 1 - All Subjects End of Cross-Over 1 - All Subjects End of Stabilization 2 - All Subjects End of Cross-Over 2 - All Subjects End of Stabilization 3 - All Subjects End of Study - All Subjects
    Number of subjects analysed
    44
    44
    42
    43
    43
    36
    43
    Units: kilograms
    median (inter-quartile range (Q1-Q3))
        IGIV then Placebo (N= 22, 22, 22, 22, 22, 17, 21)
    27.98 (22.35 to 36.35)
    29.52 (23.28 to 36.98)
    29.79 (20.48 to 37.88)
    29.17 (21.68 to 37.7)
    26.58 (13.67 to 32.83)
    28.97 (15.95 to 34.38)
    29.68 (14.72 to 34.35)
        Placebo then IGIV (N= 22, 22, 20, 21, 21, 19, 22)
    27.23 (18.73 to 34.45)
    28.23 (19.72 to 36.8)
    20.28 (9.61 to 33.44)
    26.92 (17.52 to 37.72)
    27.35 (21.58 to 37.12)
    25.72 (20.18 to 36.55)
    24.98 (16.02 to 35.85)
    No statistical analyses for this end point

    Secondary: Mean Relative Change in Grip Strength in the Less Affected Hand

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    End point title
    Mean Relative Change in Grip Strength in the Less Affected Hand
    End point description
    Relative Change is defined as 100 * (End of the Cross-Over Period - Baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing. Population: Intent to Treat.
    End point type
    Secondary
    End point timeframe
    Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
    End point values
    Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1 Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2 Arm 2: Placebo Then IGIV, 10% - Placebo Cross-over Period 1 Arm 2: Placebo Then IGIV, 10% - IGIV, 10% Cross-over Period 2
    Number of subjects analysed
    22
    22
    20
    21
    Units: Percent change in grip strength
        arithmetic mean (confidence interval 95%)
    -2.52 (-7.9 to 2.85)
    -17.96 (-29.81 to -6.1)
    -29.22 (-40.62 to -17.83)
    19.67 (-10.84 to 50.17)
    No statistical analyses for this end point

    Secondary: Proportion of Subjects That Were Accelerated Forward into the Next Stabilization Phase (ie Switched to Open-Label IGIV, 10%)

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    End point title
    Proportion of Subjects That Were Accelerated Forward into the Next Stabilization Phase (ie Switched to Open-Label IGIV, 10%)
    End point description
    Subjects were permitted to switch from blinded treatment with placebo or IGIV, 10% to open label IGIV, 10% if they and investigator agreed that deterioration had occurred to the extent that the subject had unacceptable difficulty carrying out daily activities involving the affected muscles, or decline in grip strength of ≥50% in the more affected hand had occurred. Population: Intent to Treat.
    End point type
    Secondary
    End point timeframe
    During the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
    End point values
    Accelerated Switch During IGIV, 10% and Placebo Accelerated Switch During Placebo, But Not IGIV, 10% Accelerated Switch During IGIV, 10%, But Not Placebo No Accelerated Switch During IGIV, 10% or Placebo
    Number of subjects analysed
    42
    42
    42
    42
    Units: Proportion of subjects
        number (not applicable)
    0
    69
    2.4
    28.6
    No statistical analyses for this end point

    Secondary: Patient Global Impression of Change

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    End point title
    Patient Global Impression of Change
    End point description
    Patient Global Impression of Change was measured on an ordinal scale of 1-7, higher scores representing greater perceived deterioration since the previous efficacy assessment (ranging from (1) very much improved to very much worse (7)). 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse. Population: Intent to Treat.
    End point type
    Secondary
    End point timeframe
    Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
    End point values
    End of Stabilization 1 - All Subjects End of Cross-Over 1 - All Subjects End of Stabilization 2 - All Subjects End of Cross-Over 2 - All Subjects End of Stabilization 3 - All Subjects End of Study - All Subjects
    Number of subjects analysed
    44
    42
    43
    43
    36
    43
    Units: Scores on a scale
    median (inter-quartile range (Q1-Q3))
        IGIV, 10% then Placebo (N= 22, 22, 22, 21, 17, 21)
    4 (3 to 4)
    4 (4 to 4)
    4 (4 to 4)
    5 (5 to 6)
    2 (2 to 4)
    4 (3 to 4)
        Placebo then IGIV, 10% (N= 22, 20, 21, 21, 19, 22)
    4 (3 to 4)
    6 (5 to 6)
    3 (2 to 3)
    4 (3 to 4)
    4 (4 to 4)
    4 (4 to 4)
    No statistical analyses for this end point

    Secondary: Overall Disability Sum Score

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    End point title
    Overall Disability Sum Score
    End point description
    The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability. Overall disability sum score = arm disability scale (range 0–5) + leg disability scale (range 0–7); Overall Range: 0 (no signs of disability) to 12 (maximum disability). Population: Intent to Treat.
    End point type
    Secondary
    End point timeframe
    Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
    End point values
    Before Stabilization 1 - All Subjects End of Stabilization 1 - All Subjects End of Cross-Over 1 - All Subjects End of Stabilization 2 - All Subjects End of Cross-Over 2 - All Subjects End of Stabilization 3 - All Subjects End of Study - All Subjects
    Number of subjects analysed
    44
    44
    42
    43
    43
    36
    43
    Units: Scores on a scale
    median (inter-quartile range (Q1-Q3))
        IGIV then Placebo (N= 22, 22, 22, 22, 22, 17, 21)
    3 (2 to 4)
    2 (2 to 4)
    3 (2 to 4)
    2 (2 to 4)
    3 (2 to 4)
    2 (2 to 4)
    2 (2 to 4)
        Placebo then IGIV (N= 22, 22, 20, 21, 21, 19, 22)
    3 (2 to 4)
    3 (2 to 4)
    4 (3 to 5)
    3 (2 to 4)
    3 (2 to 4)
    4 (2 to 4)
    3 (2 to 4)
    No statistical analyses for this end point

    Secondary: Overall Disability Sum Score - Standardized

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    End point title
    Overall Disability Sum Score - Standardized
    End point description
    The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability. Overall disability sum score = arm disability scale (range 0–5) + leg disability scale (range 0–7); Overall Range: 0 (no signs of disability) to 12 (maximum disability). This was standardized to a scale of 0 to 100 (the best score being 100) to allow calculation of relative changes. Population: Intent to Treat.
    End point type
    Secondary
    End point timeframe
    Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
    End point values
    Before Stabilization 1 - All Subjects End of Stabilization 1 - All Subjects End of Cross-Over 1 - All Subjects End of Stabilization 2 - All Subjects End of Cross-Over 2 - All Subjects End of Stabilization 3 - All Subjects End of Study - All Subjects
    Number of subjects analysed
    44
    44
    42
    43
    43
    36
    43
    Units: Scores on a scale
    median (inter-quartile range (Q1-Q3))
        IGIV then Placebo (N= 22, 22, 22, 22, 22, 17, 21)
    75 (66.7 to 83.3)
    83.3 (66.7 to 83.3)
    79.2 (66.7 to 83.3)
    83.3 (66.7 to 83.3)
    75 (66.7 to 83.3)
    83.3 (66.7 to 83.3)
    83.3 (66.7 to 83.3)
        Placebo then IGIV (N= 22, 22, 20, 21, 21, 19, 22)
    75 (66.7 to 83.3)
    75 (66.7 to 83.3)
    66.7 (58.3 to 75)
    75 (66.7 to 83.3)
    75 (66.7 to 83.3)
    66.7 (66.7 to 83.3)
    75 (66.7 to 83.3)
    No statistical analyses for this end point

    Secondary: Mean Relative Change in Overall Disability Sum Score

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    End point title
    Mean Relative Change in Overall Disability Sum Score
    End point description
    Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The overall disability sum scale (based on Merkies et al., 2002) is a patient questionnaire that measures disability (from 0, “no signs of disability” to 12, “most severe disability”). This was standardized to a scale of 0 to 100 (the best score being 100) to allow calculation of relative changes. Population: Intent to Treat.
    End point type
    Secondary
    End point timeframe
    Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
    End point values
    Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1 Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2 Arm 2: Placebo Then IGIV, 10% - Placebo Cross-over Period 1 Arm 2: Placebo Then IGIV, 10% - IGIV, 10% Cross-over Period 2
    Number of subjects analysed
    22
    22
    20
    21
    Units: Percent change in score
        arithmetic mean (confidence interval 95%)
    -3.14 (-6.55 to 0.27)
    -5.77 (-10.33 to -1.2)
    -8.46 (-12.81 to -4.11)
    0.92 (-2.88 to 4.73)
    No statistical analyses for this end point

    Secondary: Time Required by Subjects to Complete the 9 Hole Peg Board Test (9-HPT) with the Dominant Hand

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    End point title
    Time Required by Subjects to Complete the 9 Hole Peg Board Test (9-HPT) with the Dominant Hand
    End point description
    The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Subjects picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, subjects removed the pegs one at a time and returned them to the container as quickly as possible. Each subject did this two times with their dominant hand. The 9-HCT objective is to see how fast subjects could put all of the pegs in and take them out again. Population: Intent to Treat.
    End point type
    Secondary
    End point timeframe
    Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
    End point values
    Before Stabilization 1 - All Subjects End of Stabilization 1 - All Subjects End of Cross-Over 1 - All Subjects End of Stabilization 2 - All Subjects End of Cross-Over 2 - All Subjects End of Stabilization 3 - All Subjects End of Study - All Subjects
    Number of subjects analysed
    44
    44
    42
    43
    43
    36
    43
    Units: Seconds
    median (inter-quartile range (Q1-Q3))
        IGIV then Placebo (N= 22, 22, 22, 22, 22, 17, 21)
    20.75 (19.5 to 27.5)
    22 (19.5 to 29)
    20.25 (18 to 29)
    21 (18 to 24.5)
    20.5 (18.5 to 27.5)
    20.5 (19 to 24.5)
    20 (19 to 25.5)
        Placebo then IGIV (N= 22, 22, 20, 21, 21, 19, 22)
    26.75 (20.5 to 39)
    25.25 (19 to 33.5)
    27.75 (23 to 43.5)
    24.5 (19 to 34.5)
    25 (20 to 30.5)
    27.5 (20.5 to 35.5)
    26.25 (19.5 to 33)
    No statistical analyses for this end point

    Secondary: Mean Relative Change in Time Required by Subjects to Complete the 9 Hole Peg Board Test (9-HPT) With the Dominant Hand

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    End point title
    Mean Relative Change in Time Required by Subjects to Complete the 9 Hole Peg Board Test (9-HPT) With the Dominant Hand
    End point description
    Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Subjects picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, subjects removed the pegs one at a time and returned them to the container as quickly as possible. Each subject did this two times with their dominant hand. The 9-HCT objective is to see how fast subjects could put all of the pegs in and take them out again. Population: Intent to Treat.
    End point type
    Secondary
    End point timeframe
    Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
    End point values
    Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1 Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2 Arm 2: Placebo Then IGIV, 10% - Placebo Cross-over Period 1 Arm 2: Placebo Then IGIV, 10% - IGIV, 10% Cross-over Period 2
    Number of subjects analysed
    22
    22
    20
    21
    Units: Percent change in time
        arithmetic mean (confidence interval 95%)
    -2.57 (-9.99 to 4.86)
    3.9 (-4.59 to 12.39)
    29.89 (12.46 to 47.31)
    4.89 (-9.45 to 19.23)
    No statistical analyses for this end point

    Secondary: Time Required by Subjects to Complete the 9 Hole Peg Board Test (9-HPT) with the Non-Dominant Hand

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    End point title
    Time Required by Subjects to Complete the 9 Hole Peg Board Test (9-HPT) with the Non-Dominant Hand
    End point description
    The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Subjects picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, subjects removed the pegs one at a time and returned them to the container as quickly as possible. Each subject did this two times with their non-dominant hand. The 9-HCT objective is to see how fast subjects could put all of the pegs in and take them out again. Population: Intent to Treat.
    End point type
    Secondary
    End point timeframe
    Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
    End point values
    Before Stabilization 1 - All Subjects End of Stabilization 1 - All Subjects End of Cross-Over 1 - All Subjects End of Stabilization 2 - All Subjects End of Cross-Over 2 - All Subjects End of Stabilization 3 - All Subjects End of Study - All Subjects
    Number of subjects analysed
    44
    44
    42
    43
    43
    36
    43
    Units: Seconds
    median (inter-quartile range (Q1-Q3))
        IGIV then Placebo (N= 22, 22, 22, 22, 22, 17, 21)
    25.75 (20 to 29.5)
    22.5 (19.5 to 27)
    24 (19.5 to 28.5)
    23.5 (19.5 to 27)
    25.25 (22.5 to 29.5)
    21 (19.5 to 24.5)
    23 (20.5 to 26.5)
        Placebo then IGIV (N= 22, 22, 20, 21, 21, 19, 22)
    31.25 (22.5 to 51)
    28 (22.5 to 40)
    37.25 (26.25 to 82.75)
    31.5 (24 to 38.5)
    32.5 (22 to 41)
    30 (22.5 to 39.5)
    30 (21 to 38.5)
    No statistical analyses for this end point

    Secondary: Mean Relative Change in Time Required by Subjects to Complete the 9 Hole Peg Board Test (9-HPT) With the Non-Dominant Hand

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    End point title
    Mean Relative Change in Time Required by Subjects to Complete the 9 Hole Peg Board Test (9-HPT) With the Non-Dominant Hand
    End point description
    Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Subjects picked up the pegs one at a time (nine in total), and put them into the holes on the board as quickly as possible, in any order until all the holes were filled. Then, without pausing, subjects removed the pegs one at a time and returned them to the container as quickly as possible. Each subject did this two times with their non-dominant hand. The 9-HCT objective is to see how fast subjects could put all of the pegs in and take them out again. Population: Intent to Treat.
    End point type
    Secondary
    End point timeframe
    Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
    End point values
    Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1 Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2 Arm 2: Placebo Then IGIV, 10% - Placebo Cross-over Period 1 Arm 2: Placebo Then IGIV, 10% - IGIV, 10% Cross-over Period 2
    Number of subjects analysed
    22
    22
    20
    21
    Units: Percent change in time
        arithmetic mean (confidence interval 95%)
    4.78 (-1.65 to 11.21)
    13.06 (4.46 to 21.65)
    52.93 (26.82 to 79.05)
    8.56 (-4.88 to 22.01)
    No statistical analyses for this end point

    Secondary: Subjects' Assessment of physical functioning on a Visual Analog Scale (VAS)

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    End point title
    Subjects' Assessment of physical functioning on a Visual Analog Scale (VAS)
    End point description
    The VAS measured patients’ assessment of physical functioning on a 10 centimeter scale of 0-10, on which 0 represents “no symptoms” and 10 “disabled, unable to use affected limbs”. Population: Intent to Treat.
    End point type
    Secondary
    End point timeframe
    Week 0, then at Last infusion cycle for each study part (Day 8 of last treatment cycle for 2-week interval or Day 15 of last treatment cycle for 3 or 4 -week interval), then at the end of study visit
    End point values
    Before Stabilization 1 - All Subjects End of Stabilization 1 - All Subjects End of Cross-Over 1 - All Subjects End of Stabilization 2 - All Subjects End of Cross-Over 2 - All Subjects End of Stabilization 3 - All Subjects End of Study - All Subjects
    Number of subjects analysed
    44
    44
    42
    43
    43
    36
    43
    Units: Scores on a scale
    median (inter-quartile range (Q1-Q3))
        IGIV then Placebo (N= 22, 22, 22, 22, 22, 17, 21)
    4.8 (2.9 to 6.3)
    2.95 (1.6 to 5.1)
    4.1 (2 to 5.6)
    3.5 (1.7 to 5.1)
    6.85 (5.9 to 8.1)
    4.5 (2.6 to 5.1)
    3.7 (1.9 to 5.4)
        Placebo then IGIV (N= 22, 22, 20, 21, 21, 19, 22)
    4.95 (2.3 to 7.6)
    3.15 (2.7 to 5.5)
    7.15 (6.75 to 7.6)
    5.1 (2.3 to 6.1)
    4.6 (2.4 to 5.9)
    4.5 (2.6 to 6)
    5.15 (2.8 to 6.3)
    No statistical analyses for this end point

    Secondary: Mean Relative Change in Subjects' Assessment of Physical Functioning on a Visual Analog Scale (VAS)

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    End point title
    Mean Relative Change in Subjects' Assessment of Physical Functioning on a Visual Analog Scale (VAS)
    End point description
    Relative Change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The VAS measured patients’ assessment of physical functioning on a 10 centimeter scale of 0-10, on which 0 represents “no symptoms” and 10 “disabled, unable to use affected limbs”. Population: Intent to Treat.
    End point type
    Secondary
    End point timeframe
    Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
    End point values
    Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Cross-over Period 1 Arm 1: IGIV, 10% Then Placebo- Placebo Cross-over Period 2 Arm 2: Placebo Then IGIV, 10% - Placebo Cross-over Period 1 Arm 2: Placebo Then IGIV, 10% - IGIV, 10% Cross-over Period 2
    Number of subjects analysed
    22
    22
    20
    21
    Units: Percent change in assessment
        arithmetic mean (confidence interval 95%)
    140.92 (-1.35 to 283.19)
    321.75 (-73.45 to 716.95)
    258.09 (-100.83 to 617.01)
    5.75 (-11.54 to 23.04)
    No statistical analyses for this end point

    Secondary: Rate of related AEs per infusion

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    End point title
    Rate of related AEs per infusion
    End point description
    The total number of AEs determined by the investigator to be related to the study product that occur at any time during the study divided by the total number of infusions, and multiplied by 100. Number of infusions [N] analyzed per subject analysis set is as follows: Arm 1 - 10% Period N=104; Arm 1 - Placebo Period N=68; Arm 2 - 10% Period; Arm 2 - Placebo Period N=61; Arm 2 - 10% Period N=138. Population: Safety Dataset.
    End point type
    Secondary
    End point timeframe
    Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
    End point values
    Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period Arm 1: IGIV, 10% Then Placebo- Placebo Period Arm 2: Placebo Then IGIV, 10%- Placebo Period Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period
    Number of subjects analysed
    22
    22
    21
    21
    Units: AEs per infusion
        number (not applicable)
    4.8
    20.6
    44.3
    15.9
    No statistical analyses for this end point

    Secondary: Rate of related SAEs per infusion

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    End point title
    Rate of related SAEs per infusion
    End point description
    The total number of SAEs determined by the investigator to be related to the study product that occur at any time during the study divided by the total number of infusions, and multiplied by 100. Number of infusions [N] analyzed per subject analysis set is as follows: Arm 1 - 10% Period N=104; Arm 1 - Placebo Period N=68; Arm 2 - 10% Period; Arm 2 - Placebo Period N=61; Arm 2 - 10% Period N=138. Population: Safety Dataset.
    End point type
    Secondary
    End point timeframe
    Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
    End point values
    Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period Arm 1: IGIV, 10% Then Placebo- Placebo Period Arm 2: Placebo Then IGIV, 10%- Placebo Period Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period
    Number of subjects analysed
    22
    22
    21
    21
    Units: SAEs per infusion
        number (not applicable)
    0
    0
    0
    0.7
    No statistical analyses for this end point

    Secondary: The proportion of subjects for whom the infusion rate of any infusion was reduced and/or the infusion was interrupted or stopped for tolerability concerns/AEs

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    End point title
    The proportion of subjects for whom the infusion rate of any infusion was reduced and/or the infusion was interrupted or stopped for tolerability concerns/AEs
    End point description
    Population: Safety Dataset.
    End point type
    Secondary
    End point timeframe
    Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
    End point values
    Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period Arm 1: IGIV, 10% Then Placebo- Placebo Period Arm 2: Placebo Then IGIV, 10%- Placebo Period Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period
    Number of subjects analysed
    22
    22
    21
    21
    Units: Proportion of subjects
        number (not applicable)
    0
    0
    0
    4.8
    No statistical analyses for this end point

    Secondary: The proportion of infusions for which the infusion rate was reduced and/or the infusion was interrupted or stopped for tolerability concerns/AEs

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    End point title
    The proportion of infusions for which the infusion rate was reduced and/or the infusion was interrupted or stopped for tolerability concerns/AEs
    End point description
    Number of infusions [N] analyzed per subject analysis set is as follows: Arm 1 - 10% Period N=104; Arm 1 - Placebo Period N=68; Arm 2 - 10% Period; Arm 2 - Placebo Period N=61; Arm 2 - 10% Period N=138. Population: Safety Dataset.
    End point type
    Secondary
    End point timeframe
    Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
    End point values
    Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period Arm 1: IGIV, 10% Then Placebo- Placebo Period Arm 2: Placebo Then IGIV, 10%- Placebo Period Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period
    Number of subjects analysed
    22
    22
    21
    21
    Units: proportion of infusions
        number (not applicable)
    0
    0
    0
    0.7
    No statistical analyses for this end point

    Secondary: The proportion of infusions associated with one or more AEs related to the study product

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    End point title
    The proportion of infusions associated with one or more AEs related to the study product
    End point description
    Number of infusions [N] analyzed per subject analysis set is as follows: Arm 1 - 10% Period N=104; Arm 1 - Placebo Period N=68; Arm 2 - 10% Period; Arm 2 - Placebo Period N=61; Arm 2 - 10% Period N=138. Population: Safety Dataset.
    End point type
    Secondary
    End point timeframe
    Throughout the two study cross-over periods, approximately weeks 13-24 and weeks 37-48 (i.e. Study Parts 2 and 4)
    End point values
    Arm 1: IGIV, 10% Then Placebo- IGIV, 10% Period Arm 1: IGIV, 10% Then Placebo- Placebo Period Arm 2: Placebo Then IGIV, 10%- Placebo Period Arm 2: Placebo Then IGIV, 10%- IGIV, 10% Period
    Number of subjects analysed
    22
    22
    21
    21
    Units: proportion of infusions
        number (not applicable)
    3.8
    19.1
    34.4
    13
    No statistical analyses for this end point

    Post-hoc: Proportion of subjects with at least a 30% decline in relative grip strength in the less affected hand (measured using a DynEx digital dynamometer)

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    End point title
    Proportion of subjects with at least a 30% decline in relative grip strength in the less affected hand (measured using a DynEx digital dynamometer)
    End point description
    Relative grip strength change is defined as 100 * (End of the Cross-Over Period - baseline of Cross-Over Period) divided by baseline of Cross-Over Period. The grip strength was measured using a DynEx digital dynamometer. The result of grip strength was recorded to a resolution of 0.1 kg. For statistical analysis, the mean of (usually three) trials for cross-over sessions 1 and 2 was computed and the mean of the sessions was used in the analysis as the result of the grip strength measurement. Only if no grip strength testing could be performed the results were considered as missing. Population: Intent to Treat.
    End point type
    Post-hoc
    End point timeframe
    Baseline and last infusion cycle during the two study cross-over periods, approximately weeks 13 and 24; and weeks 37 and 48 (i.e. baseline and end of Study Parts 2 and 4)
    End point values
    Decline Only During IGIV, 10% Decline Only During Placebo Decline During Both Placebo and IGIV, 10% No Decline During Placebo and IGIV, 10%
    Number of subjects analysed
    42
    42
    42
    42
    Units: Proportion of subjects
        number (not applicable)
    0
    31
    2.4
    66.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Throughout the study period, approximately three years.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    Not known
    Reporting groups
    Reporting group title
    IGIV, 10%
    Reporting group description
    Subjects received IGIV, 10% at the same equivalent dose per week administered prior to the study (0.4 to 2.0 g per kg BW per infusion cycle)

    Reporting group title
    Placebo
    Reporting group description
    0.25% human albumin: BUMINATE 25% Albumin (Human)(Baxter Healthcare Corporation) used where licensed; otherwise Human Albumin 200 g/L Baxter Solution for Infusion was used)

    Serious adverse events
    IGIV, 10% Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 44 (4.55%)
    0 / 43 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 44 (2.27%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    IGIV, 10% Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 44 (79.55%)
    33 / 43 (76.74%)
    Injury, poisoning and procedural complications
    CONTUSION
         subjects affected / exposed
    5 / 44 (11.36%)
    2 / 43 (4.65%)
         occurrences all number
    9
    2
    Respiratory, thoracic and mediastinal disorders
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    7 / 44 (15.91%)
    0 / 43 (0.00%)
         occurrences all number
    8
    0
    SINUS CONGESTION
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 43 (0.00%)
         occurrences all number
    3
    0
    Nervous system disorders
    NEUROLOGICAL DECOMPENSATION
         subjects affected / exposed
    10 / 44 (22.73%)
    25 / 43 (58.14%)
         occurrences all number
    10
    25
    HEADACHE
         subjects affected / exposed
    16 / 44 (36.36%)
    2 / 43 (4.65%)
         occurrences all number
    34
    3
    NEUROLOGICAL SYMPTOM
         subjects affected / exposed
    3 / 44 (6.82%)
    2 / 43 (4.65%)
         occurrences all number
    3
    2
    PARAESTHESIA
         subjects affected / exposed
    3 / 44 (6.82%)
    1 / 43 (2.33%)
         occurrences all number
    4
    1
    SINUS HEADACHE
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 43 (0.00%)
         occurrences all number
    3
    0
    General disorders and administration site conditions
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    7 / 44 (15.91%)
    1 / 43 (2.33%)
         occurrences all number
    9
    1
    CHEST DISCOMFORT
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 43 (0.00%)
         occurrences all number
    3
    0
    FATIGUE
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 43 (0.00%)
         occurrences all number
    5
    0
    NASOPHARYNGITIS
         subjects affected / exposed
    3 / 44 (6.82%)
    2 / 43 (4.65%)
         occurrences all number
    3
    2
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 43 (0.00%)
         occurrences all number
    3
    0
    NAUSEA
         subjects affected / exposed
    3 / 44 (6.82%)
    2 / 43 (4.65%)
         occurrences all number
    31
    3
    TOOTHACHE
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 43 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal and connective tissue disorders
    MUSCLE SPASMS
         subjects affected / exposed
    8 / 44 (18.18%)
    2 / 43 (4.65%)
         occurrences all number
    12
    2
    MUSCULAR WEAKNESS
         subjects affected / exposed
    6 / 44 (13.64%)
    2 / 43 (4.65%)
         occurrences all number
    9
    3
    BACK PAIN
         subjects affected / exposed
    5 / 44 (11.36%)
    1 / 43 (2.33%)
         occurrences all number
    5
    2
    PAIN IN EXTREMITY
         subjects affected / exposed
    4 / 44 (9.09%)
    3 / 43 (6.98%)
         occurrences all number
    6
    3
    NECK PAIN
         subjects affected / exposed
    3 / 44 (6.82%)
    1 / 43 (2.33%)
         occurrences all number
    3
    1
    Infections and infestations
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    9 / 44 (20.45%)
    0 / 43 (0.00%)
         occurrences all number
    15
    0
    URINARY TRACT INFECTION
         subjects affected / exposed
    3 / 44 (6.82%)
    0 / 43 (0.00%)
         occurrences all number
    3
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Dec 2008
    Changes in inclusion and exclusion criteria.
    05 Jan 2010
    Rescue option for subjects who do not return to baseline after an accelerated switch described, changes in exclusion criteria, Data Monitoring Committee added, details of blinding/unblinded product added.
    01 Mar 2011
    Changes in inclusion criteria.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/11971045
    http://www.ncbi.nlm.nih.gov/pubmed/10467380
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