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出境医 / 临床实验 / Study of BHV-3241 in Subjects With Multiple System Atrophy (M-STAR)

Study of BHV-3241 in Subjects With Multiple System Atrophy (M-STAR)

Study Description
Brief Summary:
The purpose of this study is to compare the efficacy of BHV-3241 versus placebo in subjects with Multiple System Atrophy

Condition or disease Intervention/treatment Phase
Multiple System Atrophy Drug: Verdiperstat Drug: Placebo Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-blind to Sponsor, Investigator and Subject
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of BHV-3241 in Subjects With Multiple System Atrophy (M-STAR Study)
Actual Study Start Date : July 29, 2019
Estimated Primary Completion Date : October 20, 2021
Estimated Study Completion Date : September 20, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Arm 1: BHV-3241- Experimental Drug: Verdiperstat
300mg 2 -oral- capsules, BID
Placebo Comparator: Arm 2: Placebo Comparator Drug: Placebo
Matching placebo
Outcome Measures
Primary Outcome Measures :
  1. Evaluate the efficacy of BHV-3241, compared to placebo, as measured by a change from baseline in a modified Unified MSA Rating Scale (UMSARS) score at Week 48. [ Time Frame: Change from Baseline to Week 48 ]
    Measured by a change from baseline in a modified Unified MSA Rating Scale (UMSARS) score.

  2. Assess the safety and tolerability of BHV-3241, relative to placebo, in subjects with MSA. [ Time Frame: Change from Baseline to Week 48 ]
    Measured by the difference in amount and severity of adverse events including clinically significant abnormal laboratory values, and electrocardiogram (ECG) results.


Secondary Outcome Measures :
  1. Evaluate the efficacy of BHV-3241, compared to placebo, as measured by the Clinical Global Impression of Improvement (CGI-I) score at Week 48. [ Time Frame: Change from Baseline Week 48 ]
    Measured by the Clinical Global Impression of Improvement (CGI-I) score

  2. Evaluate the impact of BHV-3241 on quality of life, compared to placebo, as measured by a change from baseline in the motor and non-motor subscales of the MSA- QoL scale at Week 48. [ Time Frame: Change from Baseline to Week 48 ]
    Measured by a change from baseline in the motor and non-motor subscales of the MSA- QoL scale.

  3. Evaluate the efficacy of BHV-3241, compared to placebo, as measured by a change from baseline in the UMSARS Part I and Part II total score at Week 48. [ Time Frame: Change from Baseline to Week 48 ]
    Measured by a change from baseline in the UMSARS Part I and Part II total score


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of probable or possible MSA according to consensus clinical criteria (Gilman et al 2008), including subjects with MSA of either subtype (MSA-P or MSA-C).
  2. Able to ambulate without the assistance of another person, defined as the ability to take at least 10 steps. Use of assistive devices (e.g., walker or cane) is allowed.
  3. Anticipated survival of at least 3 years at the time of Screening, as judged by the Investigator.

Exclusion Criteria:

  1. Any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator.
  2. Diagnosis of neurological disorders, other than MSA.
Contacts and Locations

Locations
Show Show 48 study locations
Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.
Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date September 22, 2020
Actual Study Start Date  ICMJE July 29, 2019
Estimated Primary Completion Date October 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
  • Evaluate the efficacy of BHV-3241, compared to placebo, as measured by a change from baseline in a modified Unified MSA Rating Scale (UMSARS) score at Week 48. [ Time Frame: Change from Baseline to Week 48 ]
    Measured by a change from baseline in a modified Unified MSA Rating Scale (UMSARS) score.
  • Assess the safety and tolerability of BHV-3241, relative to placebo, in subjects with MSA. [ Time Frame: Change from Baseline to Week 48 ]
    Measured by the difference in amount and severity of adverse events including clinically significant abnormal laboratory values, and electrocardiogram (ECG) results.
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019) 		Efficacy of BHV-3241, compared to placebo, as measured by a change from baseline in the Unified MSA Rating Scale (UMSARS) Part I and II total score at Week 48. [ Time Frame: Change from Baseline to Week 48 ]
The UMSARS is a scale for the assessment of subjects with MSA. Part I, Historical Review, is an assessment of functioning across various areas (12 items). Part II is a Motor Examination (14 items).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
  • Evaluate the efficacy of BHV-3241, compared to placebo, as measured by the Clinical Global Impression of Improvement (CGI-I) score at Week 48. [ Time Frame: Change from Baseline Week 48 ]
    Measured by the Clinical Global Impression of Improvement (CGI-I) score
  • Evaluate the impact of BHV-3241 on quality of life, compared to placebo, as measured by a change from baseline in the motor and non-motor subscales of the MSA- QoL scale at Week 48. [ Time Frame: Change from Baseline to Week 48 ]
    Measured by a change from baseline in the motor and non-motor subscales of the MSA- QoL scale.
  • Evaluate the efficacy of BHV-3241, compared to placebo, as measured by a change from baseline in the UMSARS Part I and Part II total score at Week 48. [ Time Frame: Change from Baseline to Week 48 ]
    Measured by a change from baseline in the UMSARS Part I and Part II total score
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • Efficacy of BHV-3241,compared to placebo, as measured by the Clinical Global Impression of Change (CGI-C) score at Week 48. [ Time Frame: Change from Baseline Week 48 ]
    measure of clinician rated improvement
  • Impact of BHV-3241 on quality of life, relative to placebo, as measured by a change from baseline in the MSA-Quality of Life (MSA-QoL) scale at Week 48. [ Time Frame: Change from Baseline to Week 48 ]
    measure the quality of life perceived by patient
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of BHV-3241 in Subjects With Multiple System Atrophy
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of BHV-3241 in Subjects With Multiple System Atrophy (M-STAR Study)
Brief Summary The purpose of this study is to compare the efficacy of BHV-3241 versus placebo in subjects with Multiple System Atrophy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Double-blind to Sponsor, Investigator and Subject
Primary Purpose: Treatment
Condition  ICMJE Multiple System Atrophy
Intervention  ICMJE
  • Drug: Verdiperstat
    300mg 2 -oral- capsules, BID
  • Drug: Placebo
    Matching placebo
Study Arms  ICMJE
  • Experimental: Arm 1: BHV-3241- Experimental
    Intervention: Drug: Verdiperstat
  • Placebo Comparator: Arm 2: Placebo Comparator
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 21, 2020) 		336
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2019) 		250
Estimated Study Completion Date  ICMJE September 20, 2022
Estimated Primary Completion Date October 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Diagnosis of probable or possible MSA according to consensus clinical criteria (Gilman et al 2008), including subjects with MSA of either subtype (MSA-P or MSA-C).
  2. Able to ambulate without the assistance of another person, defined as the ability to take at least 10 steps. Use of assistive devices (e.g., walker or cane) is allowed.
  3. Anticipated survival of at least 3 years at the time of Screening, as judged by the Investigator.

Exclusion Criteria:

  1. Any condition that would interfere with the subject's ability to comply with study instructions, place the subject at unacceptable risk, and/or confound the interpretation of safety or efficacy data from the study, as judged by the Investigator.
  2. Diagnosis of neurological disorders, other than MSA.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   France,   Germany,   Italy,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03952806
Other Study ID Numbers  ICMJE BHV3241-301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biohaven Pharmaceuticals, Inc.
Study Sponsor  ICMJE Biohaven Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Biohaven Pharmaceuticals, Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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