A Study to Validate Modified UMSARS Qualitative Research

Overview

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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

Wolfgang Singer, M.D.

Open for enrollment

Contact information:

Jennifer Anderson

(507) 284-0336

adc.research@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20516794

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