A Study to Validate Modified UMSARS Qualitative Research
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-002969
About this study
The purpose of this study is to validate use of a modified Unified Multiple System Atrophy Rating Scale (UMSARS) that incorporates structured questions and additional instructions, developed by Biohaven Pharmaceuticals based on feedback from the FDA, as the primary outcome variable for assessing clinically meaningful change in Biohaven’s Phase 3 Multiple System Atrophy (MSA) Study BHV3241-301.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients with MSAC (patients with cerebellar ataxia as the predominant symptom) or MSA-P (patients with predominantly parkinsonian features) subtypes.
- Willing and able to provide informed consent.
Exclusion Criteria:
- Patients who participated in the Phase 3 study BHV3241-301.
- Patients with a clinically significant history of underlying neurological diseases beyond MSA.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Wolfgang Singer, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available