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Expanded Access Protocol of Verdiperstat in Patients With Multiple System Atrophy (MSA)

Primary Purpose

Multiple System Atrophy (MSA)

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
BHV3241, verdiperstat
Sponsored by
Biohaven Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Multiple System Atrophy (MSA) focused on measuring Multiple System Atrophy, MSA, verdiperstat, BHV3241, MPO inhibitor, Myeloperoxidase inhibitor, MSA-P, MSA-C

Eligibility Criteria

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Inclusion Criteria:

  1. with a diagnosis of probable or possible MSA documented by a physician according to consensus clinical criteria,5 including patients with MSA of either subtype, MSA-P or MSA-C.
  2. able to swallow whole tablets without crushing or chewing.
  3. with established care with a physician at the specialized MSA center involved in the protocol and will maintain this clinical care throughout the duration of the EAP.
  4. not eligible for an ongoing clinical study with verdiperstat and/or an ongoing EAP for MSA

Exclusion Criteria:

  1. Based on the Physician's judgement, any condition (including history of a clinically significant or unstable medical condition or lab abnormality) that would interfere with the patient's ability to comply with the EAP instructions, visit schedule, requirements and/or procedures, place the patient at unacceptable risk, or confound/interfere with the adequate assessment/interpretation of data; including difficulty swallowing verdiperstat tablets or any other sound medical, psychiatric and/or social reason.
  2. Presence of clinically significant thyroid disease despite treatment and/or TSH >10 mIU/ L at Screening/Baseline, confirmed by repeat.
  3. Patient is known to have acute or chronic liver disease that is clinically significant in the Prescriber's judgment
  4. First or second dose of COVID-19 vaccination within 7 days of first dose of verdiperstat.

Sites / Locations

  • PPD

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 8, 2021
Last Updated
October 4, 2022
Sponsor
Biohaven Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05086094
Brief Title
Expanded Access Protocol of Verdiperstat in Patients With Multiple System Atrophy (MSA)
Official Title
Intermediate-Size Patient Population Expanded Access Protocol of Verdiperstat in Patients With Multiple System Atrophy (MSA)
Study Type
Expanded Access

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biohaven Pharmaceuticals, Inc.

4. Oversight

5. Study Description

Brief Summary
The purpose of this expanded access program is to provide access to the investigational drug verdiperstat in patients with Multiple System Atrophy (MSA). Expanded access allows patients with a serious or a life-threatening disease or condition access to an investigational drug when no satisfactory approved treatment options are available.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple System Atrophy (MSA)
Keywords
Multiple System Atrophy, MSA, verdiperstat, BHV3241, MPO inhibitor, Myeloperoxidase inhibitor, MSA-P, MSA-C

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BHV3241, verdiperstat
Intervention Description
BHV3241/Verdiperstat 600mg BID

10. Eligibility

Sex
All
Eligibility Criteria
Inclusion Criteria: with a diagnosis of probable or possible MSA documented by a physician according to consensus clinical criteria,5 including patients with MSA of either subtype, MSA-P or MSA-C. able to swallow whole tablets without crushing or chewing. with established care with a physician at the specialized MSA center involved in the protocol and will maintain this clinical care throughout the duration of the EAP. not eligible for an ongoing clinical study with verdiperstat and/or an ongoing EAP for MSA Exclusion Criteria: Based on the Physician's judgement, any condition (including history of a clinically significant or unstable medical condition or lab abnormality) that would interfere with the patient's ability to comply with the EAP instructions, visit schedule, requirements and/or procedures, place the patient at unacceptable risk, or confound/interfere with the adequate assessment/interpretation of data; including difficulty swallowing verdiperstat tablets or any other sound medical, psychiatric and/or social reason. Presence of clinically significant thyroid disease despite treatment and/or TSH >10 mIU/ L at Screening/Baseline, confirmed by repeat. Patient is known to have acute or chronic liver disease that is clinically significant in the Prescriber's judgment First or second dose of COVID-19 vaccination within 7 days of first dose of verdiperstat.
Facility Information:
Facility Name
PPD
City
Morrisville
State/Province
North Carolina
ZIP/Postal Code
27560
Country
United States

12. IPD Sharing Statement

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Expanded Access Protocol of Verdiperstat in Patients With Multiple System Atrophy (MSA)

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