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Troriluzole Individual Patient IND Expanded Access Program

Primary Purpose

SCA, Spinocerebellar Ataxias

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Troriluzole
Sponsored by
Biohaven Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for SCA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria: Patient has confirmed diagnosis of spinocerebellar ataxia (SCA) 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 Physician's judgment 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 5, 2023
    Last Updated
    September 6, 2023
    Sponsor
    Biohaven Pharmaceuticals, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06034886
    Brief Title
    Troriluzole Individual Patient IND Expanded Access Program
    Official Title
    Expanded Access Use of Troriluzole for Spinocerebellar Ataxia
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Biohaven Pharmaceuticals, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    This is an expanded access program to provide troriuzole for treatment of spinocerebellar ataxia.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    SCA, Spinocerebellar Ataxias

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Troriluzole
    Other Intervention Name(s)
    BHV-4157

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Patient has confirmed diagnosis of spinocerebellar ataxia (SCA) 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 Physician's judgment 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Early Access Care
    Phone
    1-203-441-7938
    Ext
    170
    Email
    Troriluzole.SPIND@earlyaccesscare.com

    12. IPD Sharing Statement

    Learn more about this trial

    Troriluzole Individual Patient IND Expanded Access Program

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