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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety, Efficacy and Pharmacodynamic Study of Basmisanil (RO5186582) in Adults with Severe Motor Impairment Following an Ischemic Stroke

    Summary
    EudraCT number
    		 2015-003227-66
    Trial protocol
    		 ES  
    Global end of trial date
    03 Nov 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Nov 2018
    First version publication date
    08 Nov 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BP29937
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02928393
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG, +41 616878333, global.trial_information@roche.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 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Nov 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Nov 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of this Phase IIa, randomized, double-blind, placebo-controlled, parallel group study was to evaluate the safety, efficacy and pharmacodynamics of basmisanil in adult participants with severe motor impairment following an ischemic stroke.
    Protection of trial subjects
    All study subjects were required to read and sign an Informed Consent form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Feb 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    5
    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)
    3
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study population consisted of male and female subjects aged 40-85 years with severe motor impairment following an acute middle cerebral artery (MCA) ischemic stroke and was conducted across three sites in Spain.

    Pre-assignment
    Screening details
    		 Male and female subjects between 40-85 years old that had an acute middle cerebral artery (MCA) ischemic stroke within 3-4 days of study enrollment were eligible for the study.

    Period 1
    Period 1 title
    Overall Study (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
    		 Basmisanil
    Arm description
    		 Subjects received 240 milligrams (mg) of basmisanil (RO5186582) as granules packaged in stick packs, taken orally twice daily for 90 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Basmisanil
    Investigational medicinal product code
    Other name
    RO5186582
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 240 mg of basmisanil, taken orally, twice-daily (morning and evening), within 30 minutes of a meal for 90 days.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received the placebo equivalent to basmisanil (RO5186582) as granules packaged in stick packs, taken orally twice daily for 90 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received two stick packs of placebo, taken orally, twice daily (morning and evening), within 30 minutes of a meal for 90 days.

    Number of subjects in period 1
    		Basmisanil Placebo
    Started
    3
    2
    Completed
    3
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Basmisanil
    Reporting group description
    		 Subjects received 240 milligrams (mg) of basmisanil (RO5186582) as granules packaged in stick packs, taken orally twice daily for 90 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received the placebo equivalent to basmisanil (RO5186582) as granules packaged in stick packs, taken orally twice daily for 90 days.

    Reporting group values
    		 Basmisanil Placebo Total
    Number of subjects
    		 3 2 5
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.3 ( 11.8 ) 66.0 ( 5.7 ) -
    Gender Categorical
    Units: Subjects
        Male
    		 3 2 5
        Female
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        White
    		 2 2 4
        Unknown
    		 1 0 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 2 0 2
        Not Hispanic or Latino
    		 1 0 1
        Not Stated
    		 0 2 2
    Subject analysis sets

    Subject analysis set title
    Basmisanil A
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All study subjects were included in the safety and efficacy analyses.

    Subject analysis set title
    Basmisanil B
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All study subjects were included in the safety and efficacy analyses.

    Subject analysis set title
    Basmisanil C
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All study subjects were included in the safety and efficacy analyses.

    Subject analysis set title
    Placebo A
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All study subjects were included in the safety and efficacy analyses.

    Subject analysis set title
    Placebo B
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All study subjects were included in the safety and efficacy analyses.

    Subject analysis sets values
    		 Basmisanil A Basmisanil B Basmisanil C Placebo A Placebo B
    Number of subjects
    1
    1
    1
    1
    1
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    ( )
    ( )
    ( )
    Gender Categorical
    Units: Subjects
        Male
    1
    1
    1
    1
    1
        Female
    0
    0
    0
    0
    0
    Race (NIH/OMB)
    Units: Subjects
        White
    1
    0
    1
    1
    1
        Unknown
    0
    1
    0
    0
    0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    1
    0
    1
    0
    0
        Not Hispanic or Latino
    0
    1
    0
    0
    0
        Not Stated
    0
    0
    0
    1
    1

    End points

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    End points reporting groups
    Reporting group title
    Basmisanil
    Reporting group description
    		 Subjects received 240 milligrams (mg) of basmisanil (RO5186582) as granules packaged in stick packs, taken orally twice daily for 90 days.

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received the placebo equivalent to basmisanil (RO5186582) as granules packaged in stick packs, taken orally twice daily for 90 days.

    Subject analysis set title
    Basmisanil A
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All study subjects were included in the safety and efficacy analyses.

    Subject analysis set title
    Basmisanil B
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All study subjects were included in the safety and efficacy analyses.

    Subject analysis set title
    Basmisanil C
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All study subjects were included in the safety and efficacy analyses.

    Subject analysis set title
    Placebo A
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All study subjects were included in the safety and efficacy analyses.

    Subject analysis set title
    Placebo B
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    All study subjects were included in the safety and efficacy analyses.

    Primary: Change from Baseline in Fugl-Meyer Motor Scale (FMMS) Total Score at Day 90

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    End point title
    		 Change from Baseline in Fugl-Meyer Motor Scale (FMMS) Total Score at Day 90 [1]
    End point description
    The FMMS is a subscale of the Fugl-Meyer Assessment (FMA) scale used to evaluate and measure recovery of motor function in post-stroke participants. The subscale contains 33 items to assess upper extremity function, and 17 items to assess lower extremity function. Each item is scored on a 3-point scale, where 0 means an item cannot be performed, 1 means an item can be partially performed, and 2 means an item may be fully performed. The maximum score is 66 for upper limbs and 34 for lower limbs.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1), Day 90
    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: Statistical analyses were not performed due to low enrollment and early study termination.
    End point values
    		 Basmisanil Placebo
    Number of subjects analysed
    3
    2
    Units: None
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    29.33 ( 5.69 )
    30.50 ( 3.54 )
        Day 90
    56.33 ( 14.19 )
    60.00 ( 2.83 )
    No statistical analyses for this end point

    Primary: Number of Subjects with Adverse Events

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    End point title
    		 Number of Subjects with Adverse Events [2]
    End point description
    An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered to be adverse
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) up to 28 days after last dose of study drug
    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: Statistical analyses were not performed due to low enrollment and early study termination.
    End point values
    		 Basmisanil Placebo
    Number of subjects analysed
    3
    2
    Units: Subjects
    1
    1
    No statistical analyses for this end point

    Primary: Change from Baseline in National Institute of Health Stroke Scale (NIHSS) Score

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    End point title
    		 Change from Baseline in National Institute of Health Stroke Scale (NIHSS) Score [3]
    End point description
    NIHSS: The NIHSS is an 11-item scale administered to all study subjects developed to assess function and degree of impairment in acute post-stroke subjects. The scale contains 11 elements rating the ability to respond to questions and to obey simple commands, eye gaze, vision, facial palsy, motor function, ataxia, sensation, language, articulation, and attention. Each element is scored between 0 and 4, with 0 indicating normal function and 4 indicating complete impairment. The highest score possible is 42.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1), Days 3, 10, 30, 90, and at follow-up
    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: Statistical analyses were not performed due to low enrollment and early study termination.
    End point values
    		 Basmisanil A Basmisanil B Basmisanil C Placebo A Placebo B
    Number of subjects analysed
    1
    1
    1
    1
    1
    Units: None
    number (not applicable)
        Baseline (Day 1)
    9
    10
    9
    14
    7
        Change from Baseline at Day 3
    -1
    -2
    -3
    -3
    -1
        Change from Baseline at Day 10
    -1
    -4
    -4
    -6
    -3
        Change from Baseline at Day 30
    -3
    -5
    -5
    -9
    -3
        Change from Baseline at Day 90
    -4
    -8
    -6
    -9
    -6
        Change from Baseline at Follow-Up
    -1
    -8
    -6
    -11
    -6
    No statistical analyses for this end point

    Primary: Change from Baseline in Montreal Cognitive Assessment (MoCA) Score

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    End point title
    		 Change from Baseline in Montreal Cognitive Assessment (MoCA) Score [4]
    End point description
    The MoCA is a screening tool used to detect mild cognitive impairment in patients with dementia or stroke. Points are given for tasks completed in the following domains: visuospatial, naming, memory, attention, language, abstraction, delayed recall, and orientation. The maximum score is 30, with higher scores indicating higher ability to complete the administered tasks. Subjects unable to complete the written portion of the tool due to hemiplegia are scored on a modified scale. 99999 = N/A
    End point type
    Primary
    End point timeframe
    Baseline (Day 1), Days 30 and 90
    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: Statistical analyses were not performed due to low enrollment and early study termination.
    End point values
    		 Basmisanil A Basmisanil B Basmisanil C Placebo A Placebo B
    Number of subjects analysed
    1 [5]
    1
    1
    1
    1
    Units: None
    number (not applicable)
        Score at Baseline (Day 1)
    99999
    27
    26
    5
    15
        Score at Day 30
    11
    28
    28
    8
    25
        Score at Day 90
    99999
    27
    28
    8
    26
    Notes
    [5] - A baseline (day 1) score was not reported.
    No statistical analyses for this end point

    Primary: Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores

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    End point title
    		 Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) Scores [6]
    End point description
    The C-SSRS is used to assess the lifetime suicidality of a subject (taken at baseline), and new instances of suicidal ideation that may occur during the study (measured for each time period since the last study visit). Subjects are rated on a scale ranging from a “wish to die” to “active suicidal thought with plan and intent.”
    End point type
    Primary
    End point timeframe
    Baseline (Day 1), Days 3, 30, 60, 90, and 28 days after the last dose of study drug
    Notes
    [6] - 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: Statistical analyses were not performed due to low enrollment and early study termination.
    End point values
    		 Basmisanil A Basmisanil B Basmisanil C Placebo A Placebo B
    Number of subjects analysed
    1
    1
    1
    1
    1
    Units: Subjects
    number (not applicable)
        Suicidal Ideation
    0
    0
    0
    0
    0
        Suicidal Ideation - Lifetime
    0
    0
    0
    0
    0
        Suicidal Ideation - Past 6 Months
    0
    0
    0
    0
    0
        Suicidal Behavior
    0
    0
    0
    0
    0
        Suicidal Behavior - Lifetime
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline in Fugl-Meyer Assessment (FMA) Total Score at Day 90

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    End point title
    		 Change from Baseline in Fugl-Meyer Assessment (FMA) Total Score at Day 90
    End point description
    The FMA is a scale used to evaluate and measure recovery in post-stroke participants across five domains - motor function, sensory function, balance, range of motion, and joint pain. Items are scored on a 3-point scale, where 0 means an item cannot be performed, 1 means an item can be partially performed, and 2 means an item may be fully performed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Day 90
    End point values
    		 Basmisanil A Basmisanil B Basmisanil C Placebo A Placebo B
    Number of subjects analysed
    1
    1
    1
    1
    1
    Units: None
        Baseline (Day 1)
    129
    135
    145
    139
    142
        Change from Baseline at Day 90
    69
    49
    80
    76
    69
    No statistical analyses for this end point

    Secondary: Change from Baseline in FMA Subscale Score at Day 90

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    End point title
    		 Change from Baseline in FMA Subscale Score at Day 90
    End point description
    The FMA is a scale used to evaluate and measure recovery in post-stroke participants across five domains - motor function, sensory function, balance, range of motion, and joint pain. Items are scored on a 3-point scale, where 0 means an item cannot be performed, 1 means an item can be partially performed, and 2 means an item may be fully performed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Day 90
    End point values
    		 Basmisanil A Basmisanil B Basmisanil C Placebo A Placebo B
    Number of subjects analysed
    1
    1
    1
    1
    1
    Units: None
    number (not applicable)
        Baseline (Day 1) FM Balance Scale Score
    4
    0
    2
    4
    2
        Change in FM Balance Score, Day 90
    6
    11
    11
    10
    11
        Baseline (Day 1) FM Sensation Scale Score
    3
    24
    24
    18
    24
        Change in FM Sensation Score, Day 90
    7
    0
    0
    2
    0
        Baseline (Day 1) FM Pain Assessment Scale Score
    44
    44
    44
    44
    44
        Change in FM Pain Assessment Score, Day 90
    -3
    0
    0
    0
    0
        Baseline (Day 1) FM Range of Motion Scale Score
    44
    44
    44
    40
    44
        Change in FM Range of Motion Score, Day 90
    0
    -3
    0
    2
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline in Modified Rankin Scale (mRS) Score at Day 90

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    End point title
    		 Change from Baseline in Modified Rankin Scale (mRS) Score at Day 90
    End point description
    The mRS is a single-item scale used to measure the degree of functional independence and is commonly used with stroke patients. Subjects were rated on a scale of 1-5, as follows: 1 = No significant disability; 2 = Slight disability; 3= Moderate disability; 4 = Moderately severe disability; 5 = Severe disability.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Day 90
    End point values
    		 Basmisanil A Basmisanil B Basmisanil C Placebo A Placebo B
    Number of subjects analysed
    1
    1
    1
    1
    1
    Units: None
    number (not applicable)
        Baseline (Day 1)
    4
    4
    5
    4
    4
        Day 90/Early Termination
    3
    3
    2
    3
    1
        Change from Baseline at Day 90
    -1
    -1
    -3
    -1
    -3
    No statistical analyses for this end point

    Secondary: Plasma Concentration of Basmisanil (RO5185682)

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    End point title
    		 Plasma Concentration of Basmisanil (RO5185682)
    End point description
    Pharmacokinetic (PK) sampling was done for all subjects that received basmisanil (RO5185862).
    End point type
    Secondary
    End point timeframe
    Days 1, 3, 10, 30, and 90
    End point values
    		 Basmisanil A Basmisanil B Basmisanil C
    Number of subjects analysed
    1 [7]
    1
    1 [8]
    Units: ng/mL
    number (not applicable)
        Day 1, Hour 4
    1280
    2690
    1020
        Day 1, Hour 8
    776
    1820
    2490
        Day 3, Pre-Dose
    2170
    2460
    3870
        Day 3, Hour 4
    3480
    3290
    3210
        Day 10, Pre-Dose
    2810
    3440
    2050
        Day 30, Pre-Dose
    3660
    4100
    3290
        Day 90
    3700
    9630
    3480
    Notes
    [7] - 99999 = No value reported for time point
    [8] - 99999 = No value reported for time point
    No statistical analyses for this end point

    Secondary: Change in Infarct Lesion Volume as Determined by Magnetic Resonance Imaging (MRI)

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    End point title
    		 Change in Infarct Lesion Volume as Determined by Magnetic Resonance Imaging (MRI)
    End point description
    Infarct lesion volume was monitored using MRI. Baseline lesion measurements occurred approximately 5-7 after the stroke event.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Days 3 and 90
    End point values
    		 Basmisanil A Basmisanil B Basmisanil C Placebo A Placebo B
    Number of subjects analysed
    1
    1
    1
    1
    1
    Units: Cubic millimeters (mm3)
    number (not applicable)
        Baseline Infarct Volume
    1492.19
    23678.26
    3225.33
    90212.7
    31456.58
        Change from Baseline in Infarct Volume at Day 3
    320.62
    -3036.44
    -743.77
    -7833.17
    -1805.62
        Change from Baseline in Infarct Volume at Day 90
    1179.37
    -1867.85
    634.3
    10402.38
    -14827.85
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Baseline (Day 1) up to 28 days after last dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received the placebo equivalent to basmisanil (RO5186582) as granules packaged in stick packs, taken orally twice daily for 90 days.

    Reporting group title
    Basmisanil
    Reporting group description
    		 Subjects received 240 mg of basmisanil (RO5186582) as granules packaged in stick packs, taken orally twice daily for 90 days.

    Serious adverse events
    		 Placebo Basmisanil
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 3 (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
    		 Placebo Basmisanil
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 3 (33.33%)
    Eye disorders
    Dacryocystitis
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 3 (33.33%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Metatarsalgia
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 3 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Dec 2016
    Removed references to health authorities outside the area of study conduct; replaced Joint Monitoring Committee (JMC) with independent data monitoring committee (iDMC); clarified methods permitted to record body temperature; made Day 1 PK sample collection optional.
    24 Jul 2017
    Expanded subject population; clarified discontinuation criteria; modified interim analysis; modified caregiver eligibility requirement; clarified assessment schedule.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    03 Nov 2017
    The study was prematurely terminated by the sponsor due to low enrollment.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The low number of subjects enrolled in the study limits conclusions that may be derived from the study data.
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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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