Troriluzole Individual Patient IND Expanded Access Program
Study Details
Study Description
Brief Summary
This is an expanded access program to provide troriuzole for treatment of spinocerebellar ataxia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
This expanded access program is designed to provide access to troriluzole for patients with spinocerebellar ataxia who are not eligible for other troriluzole clinical trials, and who in the opinion of the treating physician would potentially benefit from treatment with troriluzole.
Requests by treating physicians to file a single patient investigational new drug application as part of the expanded access program for troriluzole will be considered on a case-by-case basis.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient has confirmed diagnosis of spinocerebellar ataxia (SCA)
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In the opinion and clinical judgement of the Physician, potential benefit outweighs potential risk of receiving an investigational therapy, based on the individual patient's medical history and program eligibility criteria and judged by the treating physician to be medically suitable for treatment with troriluzole.
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Adequate hepatic function
Exclusion Criteria:
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Patient is known to have acute or chronic liver disease that is clinically significant in the Physician's judgment
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Patient has a history of a clinically significant medical condition that would interfere with the patient's ability to comply with the expanded access treatment instructions or would place the patient at increased risk
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Biohaven Pharmaceuticals, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BHV4157-SCA-EAP