Expanded Access Protocol of Troriluzole in Patients With Spinocerebellar Ataxia (SCA)
January 8, 2026 updated by: Biohaven Pharmaceuticals, Inc.
Intermediate-Size Patient Population Expanded Access Protocol of Troriluzole in Patients With Spinocerebellar Ataxia (SCA)
The purpose of this expanded access protocol is to provide access to the investigational drug troriluzole in patients with spinocerebellar ataxia (SCA).
Study Overview
Detailed Description
This is an Intermediate-Size Patient Population Expanded Access Protocol designed to provide treatment use of troriluzole to patients with spinocerebellar ataxia (SCA) who are considered to be eligible in the clinical judgement of the Investigator/treating physician.
The population includes both troriluzole naive patients and patients participating in previous clinical trials with troriluzole (BHV4157-201 and BHV4157-206) who have a confirmed diagnosis of spinocerebellar ataxia.
Study Type
Expanded Access
Expanded Access Type
- Intermediate-size Population
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Description
Key Inclusion Criteria:
- Patient has a confirmed diagnosis of Spinocerebellar Ataxia (SCA), defined as either clinical evidence supporting diagnosis OR confirmed genotypic diagnosis.
- Adequate hepatic function.
Key Exclusion Criteria:
- Patient is known to have acute or chronic liver disease that is clinically significant in the judgement of the Physician.
- Patient has a history of a clinically significant medical condition that would interfere with the patients ability to comply with the expanded access protocol or would place the patient at increased risk.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
September 5, 2023
First Submitted That Met QC Criteria
September 6, 2023
First Posted (Actual)
September 13, 2023
Study Record Updates
Last Update Posted (Actual)
January 9, 2026
Last Update Submitted That Met QC Criteria
January 8, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Genetic Diseases, Inborn
- Neurodegenerative Diseases
- Heredodegenerative Disorders, Nervous System
- Spinal Cord Diseases
- Dyskinesias
- Cerebellar Diseases
- Cerebellar Ataxia
- Spinocerebellar Degenerations
- Ataxia
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Spinocerebellar Ataxias
Other Study ID Numbers
- BHV4157-401
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.