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    Clinical Trial Results:
    Response to gabapentin enacarbil in two groups of RLS patients: Previously exposed to long-term treatment with dopaminergic agents versus dopaminergic treatment-naive patients.

    Summary
    EudraCT number
    		 2014-005111-16
    Trial protocol
    		 ES  
    Global end of trial date
    30 Jun 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jun 2022
    First version publication date
    12 Jun 2022
    Other versions
    Summary report(s)
    		 Final Report signed

    Trial information

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    Trial identification
    Sponsor protocol code
    XP-IIT-0029
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sleep Research Institute
    Sponsor organisation address
    Calle Padre Damián 44, Madrid, Spain, 28036
    Public contact
    Alejandro Gómez Laguna, Sleep Research Institute, +34 913454129, aglaguna@iis.es
    Scientific contact
    Dr. Diego García-Borreguero Díaz-Varela, Sleep Research Institute, +34 913454129, dgb.investigation@iis.es
    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
    01 Sep 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jun 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the IRLS response to a two-week treatment with gabapentin enacarbil (600 mg/d) as judged by the clinical impression of the investigator in two groups of RLS patients: -A group of treatment-naïve RLS patients vs. - a similar group of patients previously treated with dopaminergics for at least 90% of the time during the last five years.
    Protection of trial subjects
    Given the short period of treatment with placebo, no specific protection measures were needed. Subjects that could not tolerate any of both treatment conditions were allowed to discontinue the trial at any time point.
    Background therapy
    		 Subjects included in the study were stratified into those that had been treated for at least 5 years with dopaminergic agents and those that had not.
    Evidence for comparator
    		 All patients were treated according to a double-blind crossover design with either gabapentin enacarbil (GBPen) or placebo. GBPen is approved for the treatment of RLS in the USA and in other non-European countries (Japan, etc.)
    Actual start date of recruitment
    01 Mar 2015
    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
    Spain: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    30
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Subjects had to meet all inclusion and exclusion criteria as pointed out in the study protocol: Patients were randomly contacted out of the database of our Institute and screened for elegibility.

    Pre-assignment period milestones
    Number of subjects started
    		 40
    Number of subjects completed
    		 39

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 due to the severity of symptoms during the sc: 1
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Blinding was completed before receiving the drug at the study site; manufactured placebo capsules were equal in aspect, size, color and taste to the active compound.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Gabapentin enacarbil
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Gabapentine enacarbryl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Oral intake of 600 mg of Gabapentine enacarbryl at 19:00

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    oral intake of placebo at 19:00

    Number of subjects in period 1
    		Gabapentin enacarbil Placebo
    Started
    39
    39
    Completed
    38
    39
    Not completed
    1
    0
         patient decision
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 40 40
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 30 30
        From 65-84 years
    		 10 10
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 23 23
        Male
    		 17 17

    End points

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    End points reporting groups
    Reporting group title
    Gabapentin enacarbil
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: The primary objective of this study is to compare the therapeutic response of two types of RLS populations (previous long-term dopaminergic treatment vs treatment naive) to a 2 week treatment period with gabapentin enacarbil by means of the IRLS.

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    End point title
    		 The primary objective of this study is to compare the therapeutic response of two types of RLS populations (previous long-term dopaminergic treatment vs treatment naive) to a 2 week treatment period with gabapentin enacarbil by means of the IRLS.
    End point description
    The primary objective of this study is to compare the therapeutic response of two types of RLS populations (previous long-term dopaminergic treatment vs treatment naive) to a 2 week treatment period with gabapentin enacarbil by means of the International Restless Legs Scale (IRLS). Change in IRLS-Total Score from baseline (Visit BL) to week 2 (V2) will be analyzed using Analysis of Covariance (ANCOVA) with the change score as the dependent variable and the independent variables of treatment and baseline (Visit BL) IRLS-Total Score. Assumptions for the ANCOVA model will be checked using plots of predicted values versus residuals as well as plots of the baseline score versus change score for each treatment (note that the small sample size limits the usefulness of a treatment by baseline interaction term for the model).
    End point type
    Primary
    End point timeframe
    Difference in change on the IRLS scale (difference between week 2 and baseline) between both groups of patients
    End point values
    		 Gabapentin enacarbil Placebo
    Number of subjects analysed
    19
    20
    Units: IRLS scale
        change in IRLS scale
    19
    20
    Attachments
    		 Untitled (Filename: Charts.pdf)
    Statistical analysis title
    		 Data analysis
    Statistical analysis description
    The primary objective of this study is to compare the therapeutic response of two types of RLS populations (previous long-term dopaminergic treatment vs treatment naive) to a 2 week treatment period with gabapentin enacarbil by means of the International Restless Legs Scale (IRLS).
    Comparison groups
    Gabapentin enacarbil v Placebo
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05 [1]
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
    Variability estimate
    Standard deviation
    Dispersion value
    1.315
    Notes
    [1] - We hypothesized that patients never treated before with dopaminergics (Group A) would benefit significantly more from a two-week treatment with gabapentin enacarbil (vs. a two-week treatment with placebo) than patients dopaminergics treated

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    A maximum period of 24 hours, from the date on which the adverse event is known.
    Adverse event reporting additional description
    Adverse events were summarized by treatment and severity. Adverse events were coded using standardized methods. Vital signs were summarized for each visit at which they are collected. Rates of concomitant medication use were summarized using WHO-coding.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 WHO-coding
    Dictionary version
    2014
    Reporting groups
    Reporting group title
    Gabapentin enacarbil
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Gabapentin enacarbil Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Gabapentin enacarbil Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 19 (47.37%)
    5 / 20 (25.00%)
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    6 / 19 (31.58%)
    5 / 20 (25.00%)
         occurrences all number
    6
    5
    Headache
         subjects affected / exposed
    4 / 19 (21.05%)
    3 / 20 (15.00%)
         occurrences all number
    4
    3
    Dizziness
         subjects affected / exposed
    3 / 19 (15.79%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    General disorders and administration site conditions
    Hot flush
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Eye disorders
    conjunctivitis
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Gastroenteritis
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Dry mouth
         subjects affected / exposed
    3 / 19 (15.79%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Nausea
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Reflux gastritis
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    Dyspepsia
    Additional description: Stomach ache
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Bronchitis
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Endocrine disorders
    Fluid retention
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Chest pain
    Additional description: Retroesternal Pain
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    Product issues
    Lethargy
    Additional description: Drowsiness
         subjects affected / exposed
    9 / 19 (47.37%)
    4 / 20 (20.00%)
         occurrences all number
    9
    4
    Infections and infestations
    Rhinitis
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 20 (5.00%)
         occurrences all number
    2
    1
    Infection
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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