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    Clinical Trial Results:
    A PLACEBO-CONTROLLED RANDOMIZED WITHDRAWAL EVALUATION OF THE EFFICACY AND SAFETY OF BACLOFEN ER CAPSULES (GRS) IN SUBJECTS WITH SPASTICITY DUE TO MULTIPLE SCLEROSIS

    Summary
    EudraCT number
    		 2016-001356-22
    Trial protocol
    		 HU  
    Global end of trial date
    25 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 May 2019
    First version publication date
    25 May 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLR_09_21
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01457352
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sun Pharma Advanced Research Company Limited
    Sponsor organisation address
    17 B Mahal Industrial Estate, Near Paperbox, off Mahakali Caves, Road, Andheri (East), India, Mumbai, India, 400 093
    Public contact
    Head- Clinical development, Sun Pharma Advanced Research Company, Ltd., +91 2266455645, clinical.trials@sparcmail.com
    Scientific contact
    Head- Clinical development, Sun Pharma Advanced Research Company, Ltd., +91 91266455645, clinical.trials@sparcmail.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
    25 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Aug 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives are to compare the continued treatment with Baclofen ER Capsules (GRS) versus down-titration to placebo in subjects stabilized on Baclofen ER Capsules (GRS) with respect to: -Demonstrating efficacy of Baclofen ER Capsules (GRS) in the treatment of spasticity -Indirectly demonstrating long-term efficacy over >12 weeks -Determining the safety profile when administered over >12 weeks
    Protection of trial subjects
    Concomitant rehabilitation therapy and/or exercises ongoing at enrolment were maintained at the same level during the study period.
    Background therapy
    		 To the extent possible, changes to the usage of proton pump inhibitors and H2-antagonists was minimized during the course of the study.
    Evidence for comparator
    		 Following conversion to an appropriate dose of Baclofen ER Capsules (GRS), subjects were treated for at least 12 weeks on a fixed dose after which they were randomly assigned to continue on the same dose or placebo. A 12-week treatment duration is sufficient to provide evidence of long-term benefit in the context of a controlled clinical trial as well as to provide safety information. Rebound spasticity occurs rapidly when the study drug is stopped abruptly, within 48 hours after stopping drug but not following gradual discontinuation. As the study drug could not be immediately discontinued due to the possibility of hallucinations and seizures upon abrupt withdrawal, subjects were down-titrated in certain increments.
    Actual start date of recruitment
    01 Oct 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
    Russian Federation: 41
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Hungary: 16
    Country: Number of subjects enrolled
    United States: 214
    Country: Number of subjects enrolled
    Ukraine: 19
    Worldwide total number of subjects
    296
    EEA total number of subjects
    22
    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)
    272
    From 65 to 84 years
    24
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 500 subjects were screened of which, 392 subjects were enrolled in the study.

    Pre-assignment
    Screening details
    		 A total of 500 subjects were screened, of which 392 subjects were enrolled in the study.

    Pre-assignment period milestones
    Number of subjects started
    		 392 [1]
    Intermediate milestone: Number of subjects
    Part 2 of the study: 376
    Number of subjects completed
    		 296

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Physician decision: 3
    Reason: Number of subjects
    		 Protocol deviation: 8
    Reason: Number of subjects
    		 Adverse event, non-fatal: 24
    Reason: Number of subjects
    		 Consent withdrawn by subject: 25
    Reason: Number of subjects
    		 worsening of condition/Other: 36
    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 study was conducted in part 1, 2, and 3: Part 1: 392 subjects Part 2: 376 subjects (SPARC0921) (One death occurred in Part 2 of the study. It was not related to treatment) Part 3: 296 subjects (SPARC0921 or Placebo0921) Efficacy and safety results are presented for Part 3 of the study per the objectives of the study.
    Period 1
    Period 1 title
    Baseline period (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
    		 SPARC0921
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    SPARC0921
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    once a day

    Arm title
    		 Placebo0921
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo0921
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    once a day

    Number of subjects in period 1
    		SPARC0921 Placebo0921
    Started
    147
    149
    Completed
    147
    146
    Not completed
    0
    3
         Consent withdrawn by subject
    -
    1
         incorrect treatment
    -
    1
         Adverse event, non-fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SPARC0921
    Reporting group description
    		 -

    Reporting group title
    Placebo0921
    Reporting group description
    		 -

    Reporting group values
    		 SPARC0921 Placebo0921 Total
    Number of subjects
    		 147 149 296
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 136 136 272
        From 65-84 years
    		 11 13 24
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48.8 ± 10.39 51.0 ± 9.39 -
    Gender categorical
    Units: Subjects
        Female
    		 105 100 205
        Male
    		 42 49 91

    End points

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    End points reporting groups
    Reporting group title
    SPARC0921
    Reporting group description
    		 -

    Reporting group title
    Placebo0921
    Reporting group description
    		 -

    Primary: Treatment failure rate

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    End point title
    		 Treatment failure rate
    End point description
    End point type
    Primary
    End point timeframe
    22 weeks
    End point values
    		 SPARC0921 Placebo0921
    Number of subjects analysed
    147
    146
    Units: percentage of subjects
        number (not applicable)
    36.1
    43.2
    Statistical analysis title
    		 Superiority
    Comparison groups
    Placebo0921 v SPARC0921
    Number of subjects included in analysis
    293
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2062
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Severity of spasticity assessed by Subject global impression of severity scale

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    End point title
    		 Severity of spasticity assessed by Subject global impression of severity scale
    End point description
    End point type
    Secondary
    End point timeframe
    Week 22
    End point values
    		 SPARC0921 Placebo0921
    Number of subjects analysed
    147
    146
    Units: percentage of subjects
    number (not applicable)
        Normal, no spasticity
    19.7
    10.3
        Borderline spasticity
    6.8
    13
        Mild spasticity
    26.5
    20.5
        Moderate spasticity
    27.9
    33.6
        Marked spasticity
    15.0
    14.4
        Severe spasticity
    4.1
    6.2
        Worst spasticity ianigable
    0
    2.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Week 22
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    Placebo0921
    Reporting group description
    		 -

    Reporting group title
    SPARC0921
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo0921 SPARC0921
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 149 (0.00%)
    3 / 147 (2.04%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    0 / 149 (0.00%)
    1 / 147 (0.68%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo0921 SPARC0921
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 149 (31.54%)
    52 / 147 (35.37%)
    Investigations
    Blood pressure increased
         subjects affected / exposed
    25 / 149 (16.78%)
    23 / 147 (15.65%)
         occurrences all number
    7
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 149 (2.68%)
    6 / 147 (4.08%)
         occurrences all number
    13
    20
    Muscle spasticity
         subjects affected / exposed
    15 / 149 (10.07%)
    14 / 147 (9.52%)
         occurrences all number
    34
    30
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 149 (0.00%)
    4 / 147 (2.72%)
         occurrences all number
    0
    13
    Musculoskeletal and connective tissue disorders
    Muscle spasm
         subjects affected / exposed
    4 / 149 (2.68%)
    2 / 147 (1.36%)
         occurrences all number
    11
    7
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 149 (0.00%)
    4 / 147 (2.72%)
         occurrences all number
    7
    14
    Urinary tract infection
         subjects affected / exposed
    6 / 149 (4.03%)
    3 / 147 (2.04%)
         occurrences all number
    13
    9

    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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