Trial · NCT03952806

Study of BHV-3241 in Participants With Multiple System Atrophy

NCT03952806, Phase 3, Completed, Biohaven Pharmaceuticals, Inc.; results first posted 2023-09-29

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study of BHV-3241 in Participants With Multiple System Atrophy. Trials, record NCT03952806. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03952806

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of BHV-3241 in Participants With Multiple System Atrophy
NCT number: NCT03952806
Status: Completed
Phases: Phase 3
Enrollment: 421 participants, actual
Lead sponsor: Biohaven Pharmaceuticals, Inc.
Conditions: Multiple System Atrophy
Interventions: Verdiperstat, Placebo
First posted: 2019-05-16
Last updated: 2023-09-29
Results first posted: 2023-09-29

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in the Modified UMSARS Score at Week 48	Baseline and Week 48	UMSARS - clinician-rated scale comprised of 4 parts: Part I (Historical Review), Part II (Motor Examination), Part III (Autonomic Examination), Part IV (Global Disability Scale). Modified UMSARS is composed of subset of 9 items from original UMSARS Part I and Part II. Responses are measured on 4-point scale ranged from 0-3, where 0= no/mild impairment, 1= moderate impairment, 2= severe impairment, 3=complete impairment. Total modified UMSARS score is sum of these 9 items, score range from 0 to 27. Higher scores indicate greater impairment.
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	Up to 100 weeks	An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in participants or clinical investigation participants administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is defined as any event that met any of the following criteria at any dose: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received study drug; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, or, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the other serious outcomes.
Secondary	Clinical Global Impression of Improvement (CGI-I) Score at Week 48	Week 48	The CGI-I is a clinician-rated scale measuring the change in the participant's clinical status from a specific point in time. It is scored on a 7- point scale, ranging from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating no change. Higher scores indicate greater impairment.
Secondary	Change From Baseline in Multiple System Atrophy Quality of Life (MSA-QoL) Motor Subscale at Week 48	Baseline and Week 48	The MSA-QoL is a participant-rated scale that was designed to measure health-related quality of life specifically in MSA. It assesses activities of daily living and has subscales for motor, nonmotor, and emotional/social domains. The MSA-QoL motor subscale includes 14 items. The response to each question ranges from 0= no problem, to 4= extreme problem, with a total scale ranging from 0-56. Higher scores indicates higher impact of the disease on the aspect measured by each subscale.
Secondary	Change From Baseline in Multiple System Atrophy Quality of Life (MSA-QoL) Non-motor Subscale at Week 48	Baseline and Week 48	The MSA-QoL is a participant-rated scale that was designed to measure health-related quality of life specifically in MSA. It assesses activities of daily living and has subscales for motor, nonmotor, and emotional/social domains. The MSA-QoL nonmotor subscale includes 12 items. The response to each question ranges from 0= no problem, to 4= extreme problem, with a total scale ranging from 0-48. Higher scores indicates higher impact of the disease on the aspect measured by each subscale.
Secondary	Change From Baseline in UMSARS Part I and Part II Total Score at Week 48	Baseline and Week 48	The UMSARS is a clinician-rated scale comprised of 4 parts: Part I (Historical Review with 12 questions), Part II (Motor Examination with 14 questions), Part III (Autonomic Examination), and Part IV (Global Disability Scale). UMSARS Part I and Part II responses are measured on a 5-point scale ranging from 0 to 4, where 0= no impairment, 1= mild impairment, 2= moderate impairment, 3= severe impairment, 4=complete impairment. Each subscale score is a sum of its items and total score is sum of all 26 items, score range from 0 to 104. Higher scores indicates greater impairment.
Secondary	Change From Baseline in Patient Global Impression of Severity (PGI-S) at Week 48	Baseline and Week 48	The PGI-S is a participant-rated scale that measures how participants perceive the severity of their illness. The PGI-S is a 1-item questionnaire on a 4-point scale ranging from 1 to 4, where, 1 = normal, 2 = mild, 3 = moderate, 4 = severe. Higher scores indicate greater impairment.
Secondary	Change From Baseline in Clinical Global Impression of Severity (CGI-S) at Week 48	Baseline and Week 48	The CGI-S is a clinician-rated scale measuring the severity of the participant's illness. It is scored on a 7- point scale ranging from 1 (normal, not ill at all) to 7 (among the most extremely ill patients). Higher scores indicate greater impairment.
Secondary	Change From Baseline in UMSARS Part III at Week 48 (Blood Pressure (BP) Only)	Baseline and Week 48	The UMSARS is a clinician-rated scale comprised of 4 parts: Part I (Historical Review), Part II (Motor Examination), Part III (Autonomic Examination) and Part IV (Global Disability Scale). Only Part III of UMSARS was analyzed. Part III of the UMSARS is an Autonomic Exam, consisting of Supine and Standing Systolic and Diastolic Blood Pressure, Heart rate and presence Orthostatic Symptoms. Only change in Orthostatic Blood Pressure reported.
Secondary	Change From Baseline in UMSARS Part III at Week 48 (Heart Rate (HR) Only)	Baseline and Week 48	The UMSARS is a clinician-rated scale comprised of 4 parts: Part I (Historical Review), Part II (Motor Examination), Part III (Autonomic Examination) and Part IV (Global Disability Scale). Only Part III of UMSARS was analyzed. Part III of the UMSARS is an Autonomic Exam, consisting of Supine and Standing Systolic and Diastolic Blood Pressure, Heart rate and presence Orthostatic Symptoms. Only change in Orthostatic Heart Rate reported.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in the Modified UMSARS Score at Week 48	Baseline and Week 48	Modified Intent to Treat (mITT) population included randomized participants who received at least 1 dose of blinded study therapy and provided a baseline and at least 1 post-baseline efficacy assessment.	units on a scale	LEAST_SQUARES_MEAN
PRIMARY	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	Up to 100 weeks	Treated population included enrolled participants who received at least 1 dose of blinded study therapy (verdiperstat or placebo).	participants	NUMBER
SECONDARY	Clinical Global Impression of Improvement (CGI-I) Score at Week 48	Week 48	mITT population.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Multiple System Atrophy Quality of Life (MSA-QoL) Motor Subscale at Week 48	Baseline and Week 48	mITT population.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Multiple System Atrophy Quality of Life (MSA-QoL) Non-motor Subscale at Week 48	Baseline and Week 48	mITT population.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in UMSARS Part I and Part II Total Score at Week 48	Baseline and Week 48	mITT population.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Patient Global Impression of Severity (PGI-S) at Week 48	Baseline and Week 48	mITT population.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Clinical Global Impression of Severity (CGI-S) at Week 48	Baseline and Week 48	mITT population.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in UMSARS Part III at Week 48 (Blood Pressure (BP) Only)	Baseline and Week 48	mITT population.	millimeter of mercury	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in UMSARS Part III at Week 48 (Heart Rate (HR) Only)	Baseline and Week 48	mITT population.	beats per minute	LEAST_SQUARES_MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in the Modified UMSARS Score at Week 48	Verdiperstat - Randomization Phase		5.20	95% Confidence Interval 4.52 to 5.89	units on a scale
Change From Baseline in the Modified UMSARS Score at Week 48	Placebo - Randomization Phase		4.85	95% Confidence Interval 4.19 to 5.51	units on a scale
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	Verdiperstat - Randomization Phase	TEAE	160		participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	Placebo - Randomization Phase	TEAE	156		participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	Verdiperstat - Randomization Phase/ Verdiperstat - OLE Phase	TEAE	95		participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	Placebo - Randomization Phase/ Verdiperstat - OLE Phase	TEAE	112		participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	Verdiperstat - Randomization Phase	Serious TEAE	44		participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	Placebo - Randomization Phase	Serious TEAE	29		participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	Verdiperstat - Randomization Phase/ Verdiperstat - OLE Phase	Serious TEAE	30		participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs	Placebo - Randomization Phase/ Verdiperstat - OLE Phase	Serious TEAE	27		participants

1 to 10 of 30Source ClinicalTrials.gov

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Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Randomization Phase (Weeks 1 Through 48)	STARTED	Verdiperstat	168
Randomization Phase (Weeks 1 Through 48)	STARTED	Placebo	168
Randomization Phase (Weeks 1 Through 48)	COMPLETED	Verdiperstat	127
Randomization Phase (Weeks 1 Through 48)	COMPLETED	Placebo	146
Randomization Phase (Weeks 1 Through 48)	NOT COMPLETED	Verdiperstat	41
Randomization Phase (Weeks 1 Through 48)	NOT COMPLETED	Placebo	22
OLE Phase (48 Weeks)	STARTED	Verdiperstat	123
OLE Phase (48 Weeks)	STARTED	Placebo	140
OLE Phase (48 Weeks)	COMPLETED	Verdiperstat	44
OLE Phase (48 Weeks)	COMPLETED	Placebo	46

1 to 10 of 12Source ClinicalTrials.gov

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Adverse events484

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Urinary tract infection	Infections and infestations	Verdiperstat - Randomization Phase	44	168	71
other	Urinary tract infection	Infections and infestations	Placebo - Randomization Phase	54	168	77
other	Urinary tract infection	Infections and infestations	Verdiperstat - Randomization Phase/Verdiperstat - OLE Phase	26	123	38
other	Urinary tract infection	Infections and infestations	Placebo - Randomization Phase/Verdiperstat - OLE Phase	29	140	40
other	COVID-19	Infections and infestations	Verdiperstat - Randomization Phase	2	168	2
other	COVID-19	Infections and infestations	Placebo - Randomization Phase	11	168	11
other	COVID-19	Infections and infestations	Verdiperstat - Randomization Phase/Verdiperstat - OLE Phase	3	123	3
other	COVID-19	Infections and infestations	Placebo - Randomization Phase/Verdiperstat - OLE Phase	5	140	5
other	Headache	Nervous system disorders	Verdiperstat - Randomization Phase	21	168	25
other	Headache	Nervous system disorders	Placebo - Randomization Phase	23	168	28

1 to 10 of 484Source ClinicalTrials.gov

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Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Verdiperstat - Randomization Phase	11	168
Total, all-cause mortality	Placebo - Randomization Phase	5	168
Total, all-cause mortality	Verdiperstat - Randomization Phase/Verdiperstat - OLE Phase	12	123
Total, all-cause mortality	Placebo - Randomization Phase/Verdiperstat - OLE Phase	10	140
Total, other adverse events	Verdiperstat - Randomization Phase	125	168
Total, other adverse events	Placebo - Randomization Phase	130	168
Total, other adverse events	Verdiperstat - Randomization Phase/Verdiperstat - OLE Phase	55	123
Total, other adverse events	Placebo - Randomization Phase/Verdiperstat - OLE Phase	71	140
Total, serious adverse events	Verdiperstat - Randomization Phase	44	168
Total, serious adverse events	Placebo - Randomization Phase	29	168

1 to 10 of 12Source ClinicalTrials.gov

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Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34115419	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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