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    Clinical Trial Results:
    A double blind, randomized, placebo controlled, crossover study of the effectiveness of oral fampridine in improving upper limb function in progressive multiple sclerosis.

    Summary
    EudraCT number
    		 2011-002561-38
    Trial protocol
    		 IE  
    Global end of trial date
    16 Feb 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Mar 2021
    First version publication date
    13 Mar 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SVUHneuro002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    St. Vincent's University Hospital
    Sponsor organisation address
    Elm Park, Dublin, Ireland,
    Public contact
    Dr. Christopher McGuigan, St. Vincent's University Hospital, 00353 12214179, C.Mcguigan@st-vincents.ie
    Scientific contact
    Dr. Christopher McGuigan, St. Vincent's University Hospital, 00353 12214179, C.Mcguigan@st-vincents.ie
    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
    04 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Feb 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of treatment with fampridine in patients with secondary progressive MS (SPMS) or primary progressive MS (PPMS) with upper limb dysfunction (as defined by a 9-HPT time of between 15-90 seconds) and Kurtzke EDSS scores in the range 4.0-7.0 on 1. Upper limb function assessed by the nine-hole peg test (9-HPT) and the Jebson Taylor Hand Function Test (JTT). 2. Scores of the MSIS-29 (physical), MSWS-12 and the Disabilities of the Arm, Shoulder and Hand Score (DASH)
    Protection of trial subjects
    Patients were reviewed at every trial visit by medical professionals with experience in MS. Direct contact details for trial investigators were given to the patient. General practitioners were informed about the patient’s participation in the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Ireland: 64
    Worldwide total number of subjects
    64
    EEA total number of subjects
    64
    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)
    57
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study recruited male and female patients between the ages of 18 – 70 years with clinically definite primary or secondary progressive multiple sclerosis. Patients will be identified in and recruited from the multiple sclerosis clinics in St. Vincent’s University Hospital, Dublin, Ireland.

    Pre-assignment
    Screening details
    		 Eligibility criteria were assessed during a separate screening visit.

    Period 1
    Period 1 title
    Baseline Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor
    Blinding implementation details
    Procedure for blinding of Fampridine versus placebo: Fampridine and placebo capsules looked identical. Fampridine and placebo were packaged in identical packaging. The label instructions were identical for both. The study was conducted in a double-blind fashion. Study treatment assignment was blinded for both the investigators and the subject. The study pharmacist retained the list of fampridine and placebo product codes.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 -
    Arm type
    		 Experimental and control

    Investigational medicinal product name
    Fampridine
    Investigational medicinal product code
    Other name
    4-Aminopyridine, Fampyra
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg tablet twice daily

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet twice daily

    Arm title
    		 Arm B
    Arm description
    		 -
    Arm type
    		 Experimental and control

    Investigational medicinal product name
    Fampridine
    Investigational medicinal product code
    Other name
    4-Aminopyridine, Fampyra
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg tablet twice daily

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet twice daily

    Number of subjects in period 1
    		Arm A Arm B
    Started
    36
    28
    Completed
    36
    28
    Period 2
    Period 2 title
    Outcome Period 1
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fampridine
    Investigational medicinal product code
    Other name
    4-Aminopyridine, Fampyra
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg tablet twice daily

    Arm title
    		 Arm B
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet twice daily

    Number of subjects in period 2
    		Arm A Arm B
    Started
    36
    28
    Completed
    35
    28
    Not completed
    1
    0
         Lost to follow-up
    1
    -
    Period 3
    Period 3 title
    Outcome Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm A
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet twice daily

    Arm title
    		 Arm B
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fampridine
    Investigational medicinal product code
    Other name
    4-Aminopyridine, Fampyra
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One 10 mg tablet twice daily

    Number of subjects in period 3
    		Arm A Arm B
    Started
    35
    28
    Completed
    33
    28
    Not completed
    2
    0
         Lost to follow-up
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 -

    Reporting group title
    Arm B
    Reporting group description
    		 -

    Reporting group values
    		 Arm A Arm B Total
    Number of subjects
    		 36 28 64
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 55.1 (45.1 to 59.5) 53.7 (45.4 to 60.9) -
    Gender categorical
    Units: Subjects
        Female
    		 23 15 38
        Male
    		 13 13 26
        Unknown
    		 0 0 0
    MS Subtype
    Units: Subjects
        Secondary Progressive MS
    		 23 22 45
        Primary Progressive MS
    		 13 5 18
        Unknown
    		 0 1 1
    On DMT
    Units: Subjects
        Yes
    		 12 13 25
        No
    		 23 14 37
        Unknown
    		 1 1 2
    Baclofen
    Units: Subjects
        No
    		 32 24 56
        Yes
    		 4 4 8
    Tizanidine
    Units: Subjects
        No
    		 33 27 60
        Yes
    		 3 1 4
    Benzo
    Units: Subjects
        No
    		 36 27 63
        Yes
    		 0 1 1
    Disease duration
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 15.7 (9.9 to 24.6) 19.2 (9.0 to 25.4) -

    End points

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    End points reporting groups
    Reporting group title
    Arm A
    Reporting group description
    		 -

    Reporting group title
    Arm B
    Reporting group description
    		 -
    Reporting group title
    Arm A
    Reporting group description
    		 -

    Reporting group title
    Arm B
    Reporting group description
    		 -
    Reporting group title
    Arm A
    Reporting group description
    		 -

    Reporting group title
    Arm B
    Reporting group description
    		 -

    Primary: Upper limb response to treatment by 9-hole peg test (dominant hand)

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    End point title
    		 Upper limb response to treatment by 9-hole peg test (dominant hand) [1]
    End point description
    An upper limb responder to fampridine was defined as a patient with both of the two “on treatment” 9-HPT assessments (assessments 4 & 5 or 7 & 8) improving 20% from the average of the baseline assessments (1, 2 & 3).
    End point type
    Primary
    End point timeframe
    At 4 and 8 weeks after baseline combined
    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: Insufficient positive cases to allow for reliable statistical analysis. As outlined in previous responses based on statistical analysis plan, we were unable to proceed to analysis due to the low number of responders.
    End point values
    		 Arm A Arm B Arm A Arm B
    Number of subjects analysed
    35
    28
    34
    27
    Units: subjects
        Response
    2
    0
    3
    2
        No response
    33
    28
    31
    25
    No statistical analyses for this end point

    Primary: Upper limb response to treatment by 9-hole peg test (non-dominant hand)

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    End point title
    		 Upper limb response to treatment by 9-hole peg test (non-dominant hand) [2]
    End point description
    An upper limb responder to fampridine was defined as a patient with both of the two “on treatment” 9-HPT assessments (assessments 4 & 5 or 7 & 8) improving 20% from the average of the baseline assessments (1, 2 & 3).
    End point type
    Primary
    End point timeframe
    At 4 and 8 weeks after baseline combined
    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: Insufficient positive cases to allow for reliable statistical analysis. As outlined in previous responses based on statistical analysis plan, we were unable to proceed to analysis due to the low number of responders.
    End point values
    		 Arm A Arm B Arm A Arm B
    Number of subjects analysed
    35
    28
    34
    27
    Units: subjects
        Response
    0
    1
    0
    2
        No response
    35
    27
    34
    25
    No statistical analyses for this end point

    Secondary: Upper limb response Jebsen Taylor Hand Function Test (dominant hand)

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    End point title
    		 Upper limb response Jebsen Taylor Hand Function Test (dominant hand)
    End point description
    A secondary measure of upper limb responsiveness will be defined as a 20% improvement in from baseline in the average time taken to complete all seven tasks on the JTT “on treatment” (assessments 4 & 5 or 7 & 8) compared with baseline assessments (assessments 1,2 & 3).
    End point type
    Secondary
    End point timeframe
    At 4 and 8 weeks after baseline combined
    End point values
    		 Arm A Arm B Arm A Arm B
    Number of subjects analysed
    35
    28
    33
    28
    Units: subjects
        Response
    3
    0
    0
    0
        No response
    32
    28
    33
    28
    No statistical analyses for this end point

    Secondary: Upper limb response Jebsen Taylor Hand Function Test (non-dominant hand)

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    End point title
    		 Upper limb response Jebsen Taylor Hand Function Test (non-dominant hand)
    End point description
    A secondary measure of upper limb responsiveness will be defined as a 20% improvement in from baseline in the average time taken to complete all seven tasks on the JTT “on treatment” (assessments 4 & 5 or 7 & 8) compared with baseline assessments (assessments 1,2 & 3).
    End point type
    Secondary
    End point timeframe
    At 4 and 8 weeks after baseline
    End point values
    		 Arm A Arm B Arm A Arm B
    Number of subjects analysed
    35
    28
    33
    28
    Units: subjects
        Response
    2
    0
    0
    1
        No response
    33
    28
    33
    27
    No statistical analyses for this end point

    Secondary: Response Timed 25 Foot Walk

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    End point title
    		 Response Timed 25 Foot Walk
    End point description
    b) A mobility responder to fampridine will be defined as a patient with both of the two “on treatment” T25FW assessments (assessments 4 & 5 or 7 & 8) being better than the maximum of any of the four “off treatment” assessments (assessments 1, 2, 3, & 9). Otherwise the patient will be deemed a non-responder.
    End point type
    Secondary
    End point timeframe
    At 4 and 8 weeks after baseline combined and 12 weeks after second baseline
    End point values
    		 Arm A Arm B Arm A Arm B
    Number of subjects analysed
    35
    27
    34
    26
    Units: subjects
        Response
    35
    27
    32
    24
        No response
    0
    0
    2
    2
    No statistical analyses for this end point

    Secondary: Change in DASH over time

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    End point title
    		 Change in DASH over time
    End point description
    Change in DASH over time across two periods. Values represent the mean difference of fampridine treatment in reference to placebo.
    End point type
    Secondary
    End point timeframe
    Over 8 weeks after baseline
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    35
    27
    Units: points
        arithmetic mean (standard error)
    -1.65 ± 5.28
    -1.65 ± 5.28
    No statistical analyses for this end point

    Secondary: Change in AMSQ over time

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    End point title
    		 Change in AMSQ over time
    End point description
    Change in AMSQ over time across two periods. Values represent the mean difference of fampridine treatment in reference to placebo.
    End point type
    Secondary
    End point timeframe
    Over 8 weeks after baseline
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    35
    27
    Units: points
        arithmetic mean (standard error)
    3.98 ± 5.52
    3.98 ± 5.52
    No statistical analyses for this end point

    Secondary: Change in MSWS over time

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    End point title
    		 Change in MSWS over time
    End point description
    Change in MSWS over time across two periods. Values represent the mean difference of fampridine treatment in reference to placebo.
    End point type
    Secondary
    End point timeframe
    Over 8 weeks from baseline
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    35
    27
    Units: points
        arithmetic mean (standard error)
    1.26 ± 7.14
    1.25 ± 7.14
    No statistical analyses for this end point

    Secondary: Change in MSIS-20 over time

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    End point title
    		 Change in MSIS-20 over time
    End point description
    Change in MSIS-20 over time across two periods. Values represent the mean difference of fampridine treatment in reference to placebo.
    End point type
    Secondary
    End point timeframe
    Over 8 weeks after baseline
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    35
    27
    Units: points
        arithmetic mean (standard error)
    -1.04 ± 6.04
    -1.04 ± 6.04
    No statistical analyses for this end point

    Secondary: Change in MSIS-9 over time

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    End point title
    		 Change in MSIS-9 over time
    End point description
    Change in MSIS-9 over time across two periods. Values represent the mean difference of fampridine treatment in reference to placebo.
    End point type
    Secondary
    End point timeframe
    Over 8 weeks after baseline
    End point values
    		 Arm A Arm B
    Number of subjects analysed
    35
    27
    Units: points
        arithmetic mean (standard error)
    4.15 ± 5.69
    4.15 ± 5.69
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    22 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    Fampridine
    Reporting group description
    		 Subjects while on fampridine treatment

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects on placebo treatment

    Serious adverse events
    		 Fampridine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 64 (0.00%)
    0 / 64 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Fampridine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 64 (50.00%)
    25 / 64 (39.06%)
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    3 / 64 (4.69%)
    4 / 64 (6.25%)
         occurrences all number
    3
    4
    Injury, poisoning and procedural complications
    Laceration to foot
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Fall
         subjects affected / exposed
    1 / 64 (1.56%)
    2 / 64 (3.13%)
         occurrences all number
    1
    2
    Vascular disorders
    Peripheral venous disease
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 64 (7.81%)
    4 / 64 (6.25%)
         occurrences all number
    5
    4
    Headache
         subjects affected / exposed
    7 / 64 (10.94%)
    0 / 64 (0.00%)
         occurrences all number
    7
    0
    Worsening hemiparesis
         subjects affected / exposed
    2 / 64 (3.13%)
    1 / 64 (1.56%)
         occurrences all number
    2
    1
    Muscle spasticity
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 64 (0.00%)
         occurrences all number
    2
    0
    Numbness
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    2
    Paresthesia
         subjects affected / exposed
    4 / 64 (6.25%)
    0 / 64 (0.00%)
         occurrences all number
    4
    0
    Tremor
         subjects affected / exposed
    2 / 64 (3.13%)
    1 / 64 (1.56%)
         occurrences all number
    2
    1
    Syncope
         subjects affected / exposed
    3 / 64 (4.69%)
    0 / 64 (0.00%)
         occurrences all number
    3
    0
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    1 / 64 (1.56%)
    2 / 64 (3.13%)
         occurrences all number
    1
    2
    Thrombocytosis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    3 / 64 (4.69%)
    1 / 64 (1.56%)
         occurrences all number
    3
    1
    Insomnia
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    Weakness
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 64 (6.25%)
    0 / 64 (0.00%)
         occurrences all number
    4
    0
    Vomiting
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    Diarrhoea
         subjects affected / exposed
    1 / 64 (1.56%)
    1 / 64 (1.56%)
         occurrences all number
    1
    1
    Constipation
         subjects affected / exposed
    0 / 64 (0.00%)
    2 / 64 (3.13%)
         occurrences all number
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 64 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Mobility decreased
         subjects affected / exposed
    1 / 64 (1.56%)
    3 / 64 (4.69%)
         occurrences all number
    1
    3
    Muscular pain
         subjects affected / exposed
    2 / 64 (3.13%)
    0 / 64 (0.00%)
         occurrences all number
    2
    0
    Pain extremity
         subjects affected / exposed
    2 / 64 (3.13%)
    3 / 64 (4.69%)
         occurrences all number
    2
    3
    Hip pain
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Ear Infection
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 64 (1.56%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Urinary Tract Infection
         subjects affected / exposed
    2 / 64 (3.13%)
    3 / 64 (4.69%)
         occurrences all number
    2
    3
    Sinusitis
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 64 (7.81%)
    0 / 64 (0.00%)
         occurrences all number
    5
    0
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 64 (3.13%)
    1 / 64 (1.56%)
         occurrences all number
    2
    1
    Influenza
         subjects affected / exposed
    1 / 64 (1.56%)
    0 / 64 (0.00%)
         occurrences all number
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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