Study of BHV-3241 in Subjects with Multiple System Atrophy (M-STAR) MSA (NCT03952806)

Status: Recruiting

 

For Diseases:

  • Multiple System Atrophy

Background

The purpose of this study is to compare the efficacy of BHV-3241 versus placebo in subjects with Multiple System Atrophy.

About this Study

A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study

Targeted Enrollment

250 participants estimated to be completed 10/20/2021

Eligibility:

  • Ages Eligible for Study: 40 Years to 80 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

  • 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).
  • 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.
  • Anticipated survival of at least 3 years at the time of Screening, as judged by the Investigator.

Exclusion Criteria:

You are not eligible to participate if you have:

  • 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.
  • Diagnosis of neurological disorders, other than MSA.

How to participate

In order to participate in a study, you must personally contact the study coordinator of any of the participating institutions by phone or by e-mail. Please use the information below to inquire about participation

  • Sites: 54 study locations, including:
    Stanford University
    UCSF
    Mayo Clinic Florida
    Beth Israel Deaconess Medical Center
    Mayo Clinic Rochester MN
    NYU School of Medicine
    Vanderbilt University Medical Center
    UT Southwestern Medical Center

    Contact: Elyse Stock, MD
    203-404-0410
    clinicaltrials@biohavenpharma.com
    Study Link