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    Clinical Trial Results:
    Effect of gabapentine as symptomatic therapy for cerebellar ataxia in degenerative and inflammatory CNS-disease

    Summary
    EudraCT number
    		 2008-005167-33
    Trial protocol
    		 DE  
    Global end of trial date
    31 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Apr 2022
    First version publication date
    18 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1210
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Charité University Medicine Berlin
    Sponsor organisation address
    Charitéplatz 1, Berlin, Germany, 10117
    Public contact
    Dr. Sarah Doss, Clinic for Neurology with Experimental Neurology, +49 030 450 560117, sarahjmdoss@gmail.com
    Scientific contact
    Dr. Sarah Doss, Clinic for Neurology with Experimental Neurology, +49 030 450 560117, sarah.doss@charite.de
    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
    31 Mar 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Effect of gabapentine versus placebo on ataxia after 7 weeks of treatment measured with cllinical ataxia rating scale (SARA)
    Protection of trial subjects
    The dosage was slowly increased to insure that the individual dosage for each patient is correct. Further to reduce the dosage if negativ efficay occurs.
    Background therapy
    		 Patients with cerebellar ataxia with coordination deficits in walking, upper and lower limb movements and oculomtoor coordination deficits are included in the trial. The cause of their atayia is either a degenerative CNS disease such as autosomal dominant Spinocerebellar Ataxia or sporadic ataxia with late onset or inflammatory CNS disease (Multiple Sclerosis).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Aug 2010
    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
    Germany: 71
    Worldwide total number of subjects
    71
    EEA total number of subjects
    71
    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)
    71
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The patients were recruited by the Ataxie-Ambulance and the residing neurologists at Charité - Universitätsmedizin Berlin

    Pre-assignment
    Screening details
    		 72 Patients were recruited. 1 was excluded due to laboratory deviations. The recruitment was nation wide.

    Period 1
    Period 1 title
    Overall treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Gabapentine Arm
    Arm description
    		 Between day 1 and day 21 the total dosage was between 600-1800mg a day. Totatel dosage was below the recommended max. dosage of 3600mg a day. Further, the medication was increased slowly to insure the patients safty and to adjust the dosage if side affect occurs.
    Arm type
    		 Experimental

    Investigational medicinal product name
    gabapentine
    Investigational medicinal product code
    GBP
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Each capsule was 300mg. The subjects received 600-1800mg each day, distributed on three daily doses.

    Arm title
    		 Placebo Arm
    Arm description
    		 The placebo was administered the same way as the investigational drug gabapentin.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Ocular use
    Dosage and administration details
    Each capsule is 300mg. 600-1800mg a day. Distributed in three daily doses

    Number of subjects in period 1
    		Gabapentine Arm Placebo Arm
    Started
    36
    35
    Completed
    29
    29
    Not completed
    7
    6
         Consent withdrawn by subject
    2
    1
         Adverse event, non-fatal
    1
    1
         no specified reasons
    2
    2
         Protocol deviation
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Gabapentine Arm
    Reporting group description
    		 Between day 1 and day 21 the total dosage was between 600-1800mg a day. Totatel dosage was below the recommended max. dosage of 3600mg a day. Further, the medication was increased slowly to insure the patients safty and to adjust the dosage if side affect occurs.

    Reporting group title
    Placebo Arm
    Reporting group description
    		 The placebo was administered the same way as the investigational drug gabapentin.

    Reporting group values
    		 Gabapentine Arm Placebo Arm Total
    Number of subjects
    		 36 35 71
    Age categorical
    Units: Subjects
        Adults 18-75
    		 36 35 71
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53.47 ± 12.06 49.72 ± 13.66 -
    Gender categorical
    Units: Subjects
        Female
    		 19 23 42
        Male
    		 17 12 29
    SARA score
    Scale for the assessment and rating of ataxia (SARA)
    Units: Score
        median (standard deviation)
    		 10 ± 7.11 9.5 ± 6.28 -
    CCFS
    Cerebellar Composite Functional Score (CCFS)
    Units: Score
        median (standard deviation)
    		 1.07 ± 0.21 1.11 ± 0.14 -
    UHDRS IV
    Unified Huntington's Disease Rating Scale (UHDRS) part IV
    Units: Score
        median (standard deviation)
    		 20 ± 5.47 21 ± 4.17 -

    End points

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    End points reporting groups
    Reporting group title
    Gabapentine Arm
    Reporting group description
    		 Between day 1 and day 21 the total dosage was between 600-1800mg a day. Totatel dosage was below the recommended max. dosage of 3600mg a day. Further, the medication was increased slowly to insure the patients safty and to adjust the dosage if side affect occurs.

    Reporting group title
    Placebo Arm
    Reporting group description
    		 The placebo was administered the same way as the investigational drug gabapentin.

    Primary: Change SARA-Score Verum vs. Placebo from V1 to V3

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    End point title
    		 Change SARA-Score Verum vs. Placebo from V1 to V3
    End point description
    End point type
    Primary
    End point timeframe
    from 0 up to 7 weeks
    End point values
    		 Gabapentine Arm Placebo Arm
    Number of subjects analysed
    29
    29
    Units: score
        median (standard deviation)
    10.5 ± 7.71
    9.5 ± 6.14
    Attachments
    		 Change SARA-Score_V1-V2-V33
    Statistical analysis title
    		 Mann-Whitney
    Statistical analysis description
    Since the data were not normally distributed, the assessment for significance was performed for the related variables using the Wilcoxon test and for the unrelated variables using the Mann-Whitney U test as non-parametric tests. Significance was assumed at a probability of error of p≤0.05.
    Comparison groups
    Gabapentine Arm v Placebo Arm
    Number of subjects included in analysis
    58
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05 [1]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - The difference in SARA difference between the first and third visit of cases and control group was found to be not significant by Mann-Whitney U test (U=335.50; Z= -1.327; p=0.185).

    Secondary: change in UHDRS part IV between V1and V3

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    End point title
    		 change in UHDRS part IV between V1and V3
    End point description
    End point type
    Secondary
    End point timeframe
    from 0 up to 7 weeks
    End point values
    		 Gabapentine Arm Placebo Arm
    Number of subjects analysed
    28
    29
    Units: score
        median (standard deviation)
    18.72 ± 5.694
    20.39 ± 4.5
    Attachments
    		 Change in UHDRS_V1-V3
    Statistical analysis title
    		 Mann-Whitney
    Comparison groups
    Gabapentine Arm v Placebo Arm
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.5 [2]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [2] - The difference in UHDRS difference between the first and third visit of cases and control group was found to be not significant by Mann-Whitney U test (U=381.500; Z= -0.421; p=0.674); Verum (Z= -0.353, p= 0.370) and placebo (Z= 0.00, p=0.537)

    Secondary: Change CCFS of total cohort

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    End point title
    		 Change CCFS of total cohort
    End point description
    End point type
    Secondary
    End point timeframe
    from V1 to V3
    End point values
    		 Gabapentine Arm Placebo Arm
    Number of subjects analysed
    28
    28
    Units: score
        median (standard error)
    1.12 ± 0.199
    1.07 ± 0.148
    Statistical analysis title
    		 Mann-Whitney
    Comparison groups
    Placebo Arm v Gabapentine Arm
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.5 [3]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [3] - The difference in CCFS between V1 to V3 significant by Mann-Whitney U test (U=336.00; Z= -0.77; p=0.480). There was no significant difference in change of CCFS in Verum group (Z= -0.072, p= 0.943) and placebo group (Z= -0.934, p= 0.35).

    Secondary: Change in measure SARA of total Cohort V1-V2

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    End point title
    		 Change in measure SARA of total Cohort V1-V2
    End point description
    End point type
    Secondary
    End point timeframe
    from V1 to V2
    End point values
    		 Gabapentine Arm Placebo Arm
    Number of subjects analysed
    32
    30
    Units: score
        median (standard error)
    -0.00 ± 1.82
    -0.75 ± 1.75
    Attachments
    		 Change SARA-Score_V1-V2-V33
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 to Day 49
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 own
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Visitation 2 Verum
    Reporting group description
    		 -

    Reporting group title
    Visitation 2 Placebo
    Reporting group description
    		 -

    Reporting group title
    Visitation 3 Verum
    Reporting group description
    		 -

    Reporting group title
    Visitation 3 Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Visitation 2 Verum Visitation 2 Placebo Visitation 3 Verum Visitation 3 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 36 (0.00%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Visitation 2 Verum Visitation 2 Placebo Visitation 3 Verum Visitation 3 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 36 (50.00%)
    10 / 35 (28.57%)
    8 / 36 (22.22%)
    3 / 35 (8.57%)
    Investigations
    Fatigue
         subjects affected / exposed
    5 / 36 (13.89%)
    3 / 35 (8.57%)
    3 / 36 (8.33%)
    2 / 35 (5.71%)
         occurrences all number
    5
    3
    3
    2
    Nervous system disorders
    increased Ataxie
         subjects affected / exposed
    3 / 36 (8.33%)
    0 / 35 (0.00%)
    2 / 36 (5.56%)
    0 / 35 (0.00%)
         occurrences all number
    3
    0
    2
    0
    decreased fine motor skills
         subjects affected / exposed
    1 / 36 (2.78%)
    0 / 35 (0.00%)
    2 / 36 (5.56%)
    1 / 35 (2.86%)
         occurrences all number
    1
    0
    2
    1
    Gait deviation
         subjects affected / exposed
    3 / 36 (8.33%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    1 / 35 (2.86%)
         occurrences all number
    3
    0
    0
    1
    Ear and labyrinth disorders
    Dizziness
         subjects affected / exposed
    9 / 36 (25.00%)
    5 / 35 (14.29%)
    3 / 36 (8.33%)
    2 / 35 (5.71%)
         occurrences all number
    9
    5
    3
    2
    Gastrointestinal disorders
    Constipation, abdomen, Nausea
         subjects affected / exposed
    5 / 36 (13.89%)
    3 / 35 (8.57%)
    0 / 36 (0.00%)
    0 / 35 (0.00%)
         occurrences all number
    5
    3
    0
    0

    More information

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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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