Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT05086094
Eligibility Criteria:
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.
Sex:
ALL
Study:
NCT05086094
Study Brief:
Protocol Section:
NCT05086094