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Trial record 5 of 14 for:    MSA | Phase 3

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

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ClinicalTrials.gov Identifier: NCT03952806
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
Biohaven Pharmaceuticals, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 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
Actual Study Start Date : July 29, 2019
Estimated Primary Completion Date : October 20, 2021
Estimated Study Completion Date : October 20, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952806


Contacts
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Contact: Robert Berman, MD 203-404-0410 clinicaltrials@biohavenpharma.com

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Sponsors and Collaborators
Biohaven Pharmaceuticals, Inc.

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Responsible Party: Biohaven Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03952806     History of Changes
Other Study ID Numbers: BHV3241-301
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biohaven Pharmaceuticals, Inc.:
Multiple System Atrophy (MSA)

Additional relevant MeSH terms:
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Atrophy
Multiple System Atrophy
Shy-Drager Syndrome
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases