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Verdiperstat for Multiple System Atrophy (M-STAR Trial)

Phase 3
Waitlist Available
Research Sponsored by Biohaven Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 100 weeks
Awards & highlights

M-STAR Trial Summary

This study is evaluating whether a drug called BHV-3241 is effective in treating people with Multiple System Atrophy.

Eligible Conditions
  • Multiple System Atrophy

M-STAR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 100 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 100 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in the Modified UMSARS Score at Week 48
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Secondary outcome measures
Change From Baseline in Clinical Global Impression of Severity (CGI-S) at Week 48
Change From Baseline in Multiple System Atrophy Quality of Life (MSA-QoL) Motor Subscale at Week 48
Change From Baseline in Multiple System Atrophy Quality of Life (MSA-QoL) Non-motor Subscale at Week 48
+6 more

Side effects data

From 2022 Phase 2 & 3 trial • 167 Patients • NCT04436510
28%
Nausea
21%
Headache
20%
Insomnia
19%
Fall
19%
Constipation
17%
Muscular weakness
16%
Fatigue
13%
Neuromyopathy
10%
Dizziness
10%
Dysphagia
10%
Tension headache
10%
Decreased appetite
9%
Blood thyroid stimulating hormone increased
8%
Diarrhoea
8%
Salivary hypersecretion
8%
Dyspnoea
8%
Urinary tract infection
7%
Anxiety
6%
Oedema peripheral
6%
Arthralgia
6%
Back pain
6%
Urine odour abnormal
6%
Cough
3%
Dysarthria
3%
Pain in extremity
2%
Febrile neutropenia
2%
Respiratory failure
2%
Pulmonary embolism
2%
Amyotrophic lateral sclerosis
1%
Ileus
1%
Failure to thrive
1%
Deep vein thrombosis
1%
Dehydration
1%
B-cell lymphoma
1%
Acute respiratory failure
1%
Abdominal pain
1%
Hepatic enzyme abnormal
1%
Aphasia
1%
Cerebral infarction
1%
Bacteraemia
1%
Bacterial sepsis
1%
COVID-19
1%
COVID-19 pneumonia
1%
Sudden death
1%
Hip fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Matching Placebo
Verdiperstat

M-STAR Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: VerdiperstatExperimental Treatment1 Intervention
Participants received verdiperstat 300 mg tablet orally once daily for 1 week, followed by 300 mg twice daily for 1 week, and then 600 mg twice daily for the remaining 46 weeks of the double-blind phase. Participants who completed the double-blind phase were offered the opportunity to enroll in an open-label extension (OLE) phase to continue verdiperstat 600 mg twice daily for 48 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants received placebo matching with verdiperstat for 48 weeks. Participants who completed the double-blind phase were offered the opportunity to enroll in an OLE phase to receive verdiperstat 600 mg tablet orally twice daily for 48 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Verdiperstat
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Biohaven Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
36,714 Total Patients Enrolled
2 Trials studying Multiple System Atrophy
19 Patients Enrolled for Multiple System Atrophy

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Virginia
What site did they apply to?
John Hopkins University
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

MSA diagnosis May 1 of this year. Met with neuro and movement disorder specialist and am willing to try whatever I can that might help.
PatientReceived 2+ prior treatments
Recent research and studies
Movement DisordersJournal
Development and Validation of a <scp>patient‐reported</scp> Outcome Measure of Ataxia
Schmahmann, Jeremy D., Samantha Pierce, Jason MacMore, and Gilbert J. L'Italien. 2021. “Development and Validation of a patient‐reported Outcome Measure of Ataxia”. Movement Disorders. Wiley. doi:10.1002/mds.28670.
clinicaltrials.govStudy
Study of BHV-3241 in Participants With Multiple System Atrophy
2019. "Study of BHV-3241 in Participants With Multiple System Atrophy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03952806.
~74 spots leftby Apr 2025
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