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
• Status: Available

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
• 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
• 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.

Related Conditions & MeSH terms

• Ataxia
• Cerebellar Ataxia
• Spinocerebellar Ataxias
• Spinocerebellar Degenerations

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.