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NCT06034886 Clinical Trial

Expanded Access Protocol of Troriluzole in Patients With Spinocerebellar Ataxia (SCA)

Spinocerebellar Ataxias Clinical Trial

Official title:
Intermediate-Size Patient Population Expanded Access Protocol of Troriluzole in Patients With Spinocerebellar Ataxia

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT06034886
Other study ID # BHV4157-401
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date February 2024
Source Biohaven Pharmaceuticals, Inc.
Contact Early Access Care
Phone 1-203-441-7938
Email Troriluzole.SPIND@earlyaccesscare.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

The purpose of this expanded access program is to provide access to the investigational drug troriluzole in patients with spinocerebellar ataxia (SCA). Expanded access allows patients with a life threatening disease or condition access to an investigational drug when no satisfactory approved treatment options are available.

Description:

This is an Intermediate-Size Patient Population Expanded Access Protocol designed to provide treatment access with troriluzole to patients with spinocerebellar ataxia who are considered to be eligible in the clinical judgement of the Investigator. 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.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient has a confirmed diagnosis of Spinocerebellar Ataxia - 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. - Adequate hepatic function. 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Troriluzole
BHV-4157 140mg, 200mg or 280mg once daily by mouth. Dose based on dose received in parent study.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Biohaven Pharmaceuticals, Inc.
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