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    Clinical Trial Results:
    Single Arm Study to Assess Comprehensive Infusion Guidance for the Management of the Infusion Associated Reaction (IARs) in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated with LEMTRADA

    Summary
    EudraCT number
    2014-000092-62
    Trial protocol
    BE   NL   ES   FR  
    Global end of trial date
    01 Apr 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Apr 2017
    First version publication date
    16 Apr 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LPS13650
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02205489
    WHO universal trial number (UTN)
    U1111-1153-3922
    Other trial identifiers
    Study Name: EMERALD
    Sponsors
    Sponsor organisation name
    Genzyme Corporation
    Sponsor organisation address
    500 Kendall Street, Cambridge, MA, United States, 02142
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.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
    10 Jun 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Apr 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the distribution of infusion associated reactions (IARs) by severity grade when alemtuzumab is administered to relapsing-remitting multiple sclerosis (RRMS) subjects who will be medicated according to a specified algorithm designed to manage IARs.
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    The following alemtuzumab-associated medications were to be administered to all study subjects: cetirizine 10 mg tablet or equivalent on Day 0 of both periods and post each infusion; ranitidine or esomeprazole, or equivalents, on Day 0 of both periods and pre- and post each infusion; methylprednisolone 1000 mg tablet on Day 0 of both periods; paracetamol 500 mg tablet or equivalent prior to each infusion; acyclovir 200 mg tablet or equivalent pre- and post each infusion, and daily through Day 30 of both periods; diphenhydramine 25 mg intravenously or equivalent prior to each infusion; methylprednisolone 1000 mg intravenously prior to each infusion (dose reduced after Day 1 and 2 of each period). During and post infusion, subjects could also receive as needed: diphenhydramine or equivalent, paracetamol or equivalent, ondansetron or equivalent, esomeprazole or equivalent, ibuprofen or equivalent (post infusion only).
    Evidence for comparator
    -
    Actual start date of recruitment
    20 Oct 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    48 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 7
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    France: 31
    Worldwide total number of subjects
    58
    EEA total number of subjects
    58
    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)
    58
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 19 sites in 4 countries from 20 October 2014 to 01 April 2016. A total of 61 subjects were screened, of whom 58 subjects were enrolled in the study. Screen failures were mainly due to the subjects falling under exclusion criteria.

    Pre-assignment
    Screening details
    The study consisted of 2 Periods: Period 1 (30 days) and Period 2 (30 days). Period 2 began 12 months after the start of Period 1. Safety was assessed monthly in interval between Period 1 and 2.

    Period 1
    Period 1 title
    Study Period 1
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Alemtuzumab: Period 1
    Arm description
    Alemtuzumab 12 mg per day administered as intravenous (IV) infusion, once a day for 5 consecutive days (from Day 1 to Day 5) along with alemtuzumab-associated medications (described under “Trial Information/Background Therapy”).
    Arm type
    Experimental

    Investigational medicinal product name
    Alemtuzumab
    Investigational medicinal product code
    GZ402673
    Other name
    Lemtrada
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Alemtuzumab was administered as IV infusion over approximately 4 hours.

    Number of subjects in period 1
    Alemtuzumab: Period 1
    Started
    58
    Completed
    52
    Not completed
    6
         Physician decision
    1
         Adverse event
    3
         Consent withdrawn by subject
    1
         Lost to follow-up
    1
    Period 2
    Period 2 title
    Study Period 2
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Alemtuzumab: Period 2
    Arm description
    Alemtuzumab 12 mg per day administered as IV infusion, once a day for 3 consecutive days (from Day 1 to Day 3) along with alemtuzumab-associated medications (described under “Trial Information/Background Therapy”).
    Arm type
    Experimental

    Investigational medicinal product name
    Alemtuzumab
    Investigational medicinal product code
    GZ402673
    Other name
    Lemtrada
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Alemtuzumab was administered as IV infusion over approximately 4 hours.

    Number of subjects in period 2
    Alemtuzumab: Period 2
    Started
    52
    Completed
    54
    Joined
    2
         Subjects not completed Period1 but entered Period2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Alemtuzumab: Period 1
    Reporting group description
    Alemtuzumab 12 mg per day administered as intravenous (IV) infusion, once a day for 5 consecutive days (from Day 1 to Day 5) along with alemtuzumab-associated medications (described under “Trial Information/Background Therapy”).

    Reporting group values
    Alemtuzumab: Period 1 Total
    Number of subjects
    58 58
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    36.42 ± 8.11 -
    Gender categorical
    Units: Subjects
        Female
    35 35
        Male
    23 23

    End points

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    End points reporting groups
    Reporting group title
    Alemtuzumab: Period 1
    Reporting group description
    Alemtuzumab 12 mg per day administered as intravenous (IV) infusion, once a day for 5 consecutive days (from Day 1 to Day 5) along with alemtuzumab-associated medications (described under “Trial Information/Background Therapy”).
    Reporting group title
    Alemtuzumab: Period 2
    Reporting group description
    Alemtuzumab 12 mg per day administered as IV infusion, once a day for 3 consecutive days (from Day 1 to Day 3) along with alemtuzumab-associated medications (described under “Trial Information/Background Therapy”).

    Subject analysis set title
    Alemtuzumab: Overall Study (with Monthly Safety Monitoring)
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Alemtuzumab 12 mg per day administered as IV infusion, once a day for 5 consecutive days (from Day 1 to Day 5) in Period 1 and for 3 consecutive days (from Day 1 to Day 3) during Period 2, along with alemtuzumab-associated medications (described under “Trial Information/Background Therapy”). Period 2 began 12 months after the start of Period 1. Safety was assessed monthly in interval between Period 1 and 2.

    Primary: Percentage of Subjects with IARs by Severity Grade

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    End point title
    Percentage of Subjects with IARs by Severity Grade [1]
    End point description
    An IAR was defined as any treatment emergent adverse event (TEAE) that occurred during or within 24 hours after alemtuzumab infusion. This summary includes events occurring during Period 1 and/or Period 2. Toxicity grade (severity) of adverse events was based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.03: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening) and Grade 5 (death). Analysis was performed on safety set defined as all enrolled subjects who received at least part of a dose of the investigational medicinal product (IMP) during Period 1 or 2. Only those grade categories, in which at least 1 subject had event, were reported.
    End point type
    Primary
    End point timeframe
    From the first administration of IMP (Day 1) to 24 hours after each infusion of Period 1 and Period 2
    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: As there was no comparator arm and no hypothesis to be tested, no statistical analysis was performed.
    End point values
    Alemtuzumab: Overall Study (with Monthly Safety Monitoring)
    Number of subjects analysed
    58
    Units: percentage of subjects
    number (confidence interval 95%)
        Grade 1 - Mild
    87.9 (76.7 to 95)
        Grade 2 - Moderate
    62.1 (48.4 to 74.5)
        Grade 3 - Severe
    10.3 (3.9 to 21.2)
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Individual IARs Occurring with >5% Incidence

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    End point title
    Percentage of Subjects with Individual IARs Occurring with >5% Incidence [2]
    End point description
    An IAR was defined as any TEAE that occurred during or within 24 hours after alemtuzumab infusion. This summary includes events occurring during Period 1 and/or Period 2. Analysis was performed on safety set.
    End point type
    Primary
    End point timeframe
    From the first administration of IMP (Day 1) to 24 hours after each infusion of Period 1 and Period 2
    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: As there was no comparator arm and no hypothesis to be tested, no statistical analysis was performed.
    End point values
    Alemtuzumab: Overall Study (with Monthly Safety Monitoring)
    Number of subjects analysed
    58
    Units: percentage of subjects
    number (confidence interval 95%)
        Headache
    58.6 (44.9 to 71.4)
        Dizziness
    8.6 (2.9 to 19)
        Presyncope
    5.2 (1.1 to 14.4)
        Pyrexia
    29.3 (18.1 to 42.7)
        Fatigue
    12.1 (5 to 23.3)
        Chest Discomfort
    8.6 (2.9 to 19)
        Malaise
    5.2 (1.1 to 14.4)
        Rash
    22.4 (12.5 to 35.3)
        Pruritus
    17.2 (8.6 to 29.4)
        Erythema
    15.5 (7.4 to 27.4)
        Urticaria
    10.3 (3.9 to 21.2)
        Pruritus Generalised
    5.2 (1.1 to 14.4)
        Nausea
    17.2 (8.6 to 29.4)
        Abdominal Pain Upper
    15.5 (7.4 to 27.4)
        Diarrhoea
    10.3 (3.9 to 21.2)
        Abdominal Pain
    6.9 (1.9 to 16.7)
        Constipation
    6.9 (1.9 to 16.7)
        Bradycardia
    15.5 (7.4 to 27.4)
        Palpitations
    5.2 (1.1 to 14.4)
        Insomnia
    19 (9.9 to 31.4)
        Flushing
    10.3 (3.9 to 21.2)
        Hot Flush
    6.9 (1.9 to 16.7)
        Musculoskeletal Stiffness
    5.2 (1.1 to 14.4)
        Myalgia
    5.2 (1.1 to 14.4)
        Dyspnoea
    6.9 (1.9 to 16.7)
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Serious IARs by Severity Grade

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    End point title
    Percentage of Subjects with Serious IARs by Severity Grade [3]
    End point description
    A serious IAR was defined as any serious TEAE that occurred during or within 24 hours after alemtuzumab infusion. This summary includes events occurring during Period 1 and/or Period 2. A serious TEAE was a TEAE that resulted in death, was life-threatening, required inpatient hospitalization or caused prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. Toxicity grade (severity) of adverse events was based on CTCAE version 4.03: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening) and Grade 5 (death). Analysis was performed on safety set. Only those grade categories, in which at least 1 subject had event, were reported.
    End point type
    Primary
    End point timeframe
    From the first administration of IMP (Day 1) to 24 hours after each infusion of Period 1 and Period 2
    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: As there was no comparator arm and no hypothesis to be tested, no statistical analysis was performed.
    End point values
    Alemtuzumab: Overall Study (with Monthly Safety Monitoring)
    Number of subjects analysed
    58
    Units: percentage of subjects
    number (confidence interval 95%)
        Grade 1 - Mild
    6.9 (1.9 to 16.7)
        Grade 2 - Moderate
    6.9 (1.9 to 16.7)
        Grade 3 - Severe
    3.4 (0.4 to 11.9)
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Individual Serious IARs 

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    End point title
    Percentage of Subjects with Individual Serious IARs  [4]
    End point description
    A serious IAR was defined as any serious TEAE that occurred during or within 24 hours after alemtuzumab infusion. This summary includes events occurring during Period 1 and/or Period 2. A serious TEAE was a TEAE that resulted in death, was life-threatening, required inpatient hospitalization or caused prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. Analysis was performed on safety set.
    End point type
    Primary
    End point timeframe
    From the first administration of IMP (Day 1) to 24 hours after each infusion of Period 1 and Period 2
    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: As there was no comparator arm and no hypothesis to be tested, no statistical analysis was performed.
    End point values
    Alemtuzumab: Overall Study (with Monthly Safety Monitoring)
    Number of subjects analysed
    58
    Units: percentage of subjects
    number (confidence interval 95%)
        Bradycardia
    5.2 (1.1 to 14.4)
        Tachycardia
    1.7 (0 to 9.2)
        Hyperthermia
    1.7 (0 to 9.2)
        Pyrexia
    1.7 (0 to 9.2)
        Fibrin D Dimer Increased
    1.7 (0 to 9.2)
        Gammaglutamyl Transferase Increased
    1.7 (0 to 9.2)
        Erythema
    1.7 (0 to 9.2)
        Urticaria
    1.7 (0 to 9.2)
        Hepatocellular Injury
    1.7 (0 to 9.2)
        Hypersensitivity
    1.7 (0 to 9.2)
        Hepatitis Viral
    1.7 (0 to 9.2)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs were collected from signature of the informed consent form up to the final visit (Month 13) regardless of seriousness or relationship to investigational product. Month 13 visit was scheduled to occur at Day 30 of Period 2.
    Adverse event reporting additional description
    Reported AEs are TEAE that is AEs that developed/worsened during the period from first administration of the IMP (Day 1 of Period 1) to the end of study (Month 13).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Alemtuzumab: Overall Study (with Monthly Safety Monitoring)
    Reporting group description
    Alemtuzumab 12 mg per day administered as IV infusion, once a day for 5 consecutive days (from Day 1 to Day 5) in Period 1 and for 3 consecutive days (from Day 1 to Day 3) during Period 2, along with alemtuzumab-associated medications (described under “Trial Information/Background Therapy”). Period 2 began 12 months after start of Period 1. Safety was assessed monthly in interval between Period 1 and 2.

    Serious adverse events
    Alemtuzumab: Overall Study (with Monthly Safety Monitoring)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    19 / 58 (32.76%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Hyperthermia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Affective Disorder
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Depression
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychotic Disorder
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Spinal Column Injury
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Fibrin D Dimer Increased
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gamma-Glutamyltransferase Increased
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Human Papilloma Virus Test Positive
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences causally related to treatment / all
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Immune Thrombocytopenic Purpura
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Monoplegia
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Multiple Sclerosis Relapse
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences causally related to treatment / all
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Hepatocellular Injury
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular Purpura
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Endocrine disorders
    Basedow's Disease
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Hepatitis Viral
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Varicella Zoster Virus Infection
         subjects affected / exposed
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Alemtuzumab: Overall Study (with Monthly Safety Monitoring)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    57 / 58 (98.28%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    6 / 58 (10.34%)
         occurrences all number
    6
    Hot Flush
         subjects affected / exposed
    6 / 58 (10.34%)
         occurrences all number
    6
    Hypertension
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Chest Discomfort
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    7
    Chills
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    5
    Fatigue
         subjects affected / exposed
    12 / 58 (20.69%)
         occurrences all number
    13
    Influenza Like Illness
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    5
    Pain
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Malaise
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Pyrexia
         subjects affected / exposed
    18 / 58 (31.03%)
         occurrences all number
    21
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Depression
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Sleep Disorder
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Insomnia
         subjects affected / exposed
    14 / 58 (24.14%)
         occurrences all number
    14
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    8 / 58 (13.79%)
         occurrences all number
    8
    Palpitations
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Dyspnoea
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Dysphonia
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Epistaxis
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Oropharyngeal Pain
         subjects affected / exposed
    6 / 58 (10.34%)
         occurrences all number
    6
    Blood and lymphatic system disorders
    Lymphopenia
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    5
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    10 / 58 (17.24%)
         occurrences all number
    10
    Headache
         subjects affected / exposed
    39 / 58 (67.24%)
         occurrences all number
    62
    Multiple Sclerosis Relapse
         subjects affected / exposed
    10 / 58 (17.24%)
         occurrences all number
    10
    Muscle Spasticity
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    5
    Tremor
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Presyncope
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Uhthoff's Phenomenon
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Eye disorders
    Vision Blurred
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Ear and labyrinth disorders
    Ear Pain
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Abdominal Pain Upper
         subjects affected / exposed
    13 / 58 (22.41%)
         occurrences all number
    13
    Constipation
         subjects affected / exposed
    8 / 58 (13.79%)
         occurrences all number
    8
    Diarrhoea
         subjects affected / exposed
    7 / 58 (12.07%)
         occurrences all number
    7
    Gingival Bleeding
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Nausea
         subjects affected / exposed
    17 / 58 (29.31%)
         occurrences all number
    18
    Toothache
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Vomiting
         subjects affected / exposed
    6 / 58 (10.34%)
         occurrences all number
    6
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    11 / 58 (18.97%)
         occurrences all number
    11
    Alopecia
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Pruritus
         subjects affected / exposed
    14 / 58 (24.14%)
         occurrences all number
    16
    Erythema
         subjects affected / exposed
    10 / 58 (17.24%)
         occurrences all number
    10
    Pruritus Generalised
         subjects affected / exposed
    6 / 58 (10.34%)
         occurrences all number
    6
    Rash
         subjects affected / exposed
    22 / 58 (37.93%)
         occurrences all number
    29
    Rash Generalised
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Urticaria
         subjects affected / exposed
    9 / 58 (15.52%)
         occurrences all number
    10
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Muscle Spasms
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    4
    Musculoskeletal Stiffness
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Myalgia
         subjects affected / exposed
    6 / 58 (10.34%)
         occurrences all number
    6
    Neck Pain
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    5
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    8 / 58 (13.79%)
         occurrences all number
    8
    Gastroenteritis Viral
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Gastroenteritis
         subjects affected / exposed
    6 / 58 (10.34%)
         occurrences all number
    6
    Nasopharyngitis
         subjects affected / exposed
    15 / 58 (25.86%)
         occurrences all number
    16
    Rhinitis
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Oral Herpes
         subjects affected / exposed
    6 / 58 (10.34%)
         occurrences all number
    6
    Sinusitis
         subjects affected / exposed
    4 / 58 (6.90%)
         occurrences all number
    4
    Tonsillitis
         subjects affected / exposed
    5 / 58 (8.62%)
         occurrences all number
    5
    Upper Respiratory Tract Infection
         subjects affected / exposed
    3 / 58 (5.17%)
         occurrences all number
    3
    Urinary Tract Infection
         subjects affected / exposed
    13 / 58 (22.41%)
         occurrences all number
    14

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Sep 2015
    The principal changes were: Added Kurtzke Expanded Disability Status Scale (EDSS) score; included other equivalent antisecretory drugs such as Proton Pump Inhibitors (PPIs) in addition to H2 receptors antagonists as alemtuzumab-associated medications; clarified recording and review process of the subject diary.

    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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