Phase 3
N=336
Study of BHV-3241 in Participants With Multiple System Atrophy
Multiple System Atrophy
Bottom Line
View on ClinicalTrials.gov: NCT03952806 ↗Enrolled (actual)
336
Serious AEs
21.7%
Results posted
Sep 2023
Primary outcome: Primary: Change From Baseline in the Modified UMSARS Score at Week 48 — 5.20; 4.85 units on a scale — p=0.4656
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Verdiperstat (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Biohaven Pharmaceuticals, Inc.
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Modified UMSARS Score at Week 48 |
5.20; 4.85 | 0.4656 |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs |
160; 156; 95; 112; 44; 29 | — |
| SECONDARY Clinical Global Impression of Improvement (CGI-I) Score at Week 48 |
5.07; 5.14 | — |
| SECONDARY Change From Baseline in Multiple System Atrophy Quality of Life (MSA-QoL) Motor Subscale at Week 48 |
13.83; 13.45 | — |
| SECONDARY Change From Baseline in Multiple System Atrophy Quality of Life (MSA-QoL) Non-motor Subscale at Week 48 |
7.52; 5.56 | — |
| SECONDARY Change From Baseline in UMSARS Part I and Part II Total Score at Week 48 |
12.00; 11.34 | — |
| SECONDARY Change From Baseline in Patient Global Impression of Severity (PGI-S) at Week 48 |
0.33; 0.27 | — |
| SECONDARY Change From Baseline in Clinical Global Impression of Severity (CGI-S) at Week 48 |
0.79; 0.78 | — |
| SECONDARY Change From Baseline in UMSARS Part III at Week 48 (Blood Pressure (BP) Only) |
-2.18; -3.09; -2.87; -2.54 | — |
| SECONDARY Change From Baseline in UMSARS Part III at Week 48 (Heart Rate (HR) Only) |
0.20; -0.68 | — |
| SECONDARY Change From Baseline in UMSARS Part IV at Week 48 |
0.82; 0.85 | — |
Summary
The purpose of this study is to compare the efficacy of verdiperstat (BHV-3241) versus placebo in participants with Multiple System Atrophy
Eligibility Criteria
Inclusion Criteria
- Diagnosis of probable or possible MSA according to consensus clinical criteria (Gilman et al 2008), including participants 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
- Any condition that would interfere with the participant's ability to comply with study instructions, place the participant 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.
Data sourced from ClinicalTrials.gov (NCT03952806). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.