Open Actively Recruiting

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

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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.

Study Type
Expanded Access

Eligibility

Gender
All
Minimum Age
N/A
Maximum Age
N/A

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.

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Study Stats
Protocol No.
21-001456
Category
Neurology
Urology
Principal Investigator
Contact
Aaron Fisher
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05086094
For detailed technical eligibility, visit ClinicalTrials.gov.