ong-term Safety Study of Adjunctive Troriluzole in Subjects with Obsessive Compulsive Disorder
- Conditions
- Obsessive Compulsive DisorderMedDRA version: 20.0Level: LLTClassification code: 10002860Term: Anxiety disorder NEC Class: 10037175Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
- Registration Number
- CTIS2024-512108-20-00
- Lead Sponsor
- Biohaven Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1200
Eligible subjects who complete study BHV4157-302 or BHV4157-303 and for whom the investigator believes open-label treatment offers an acceptable risk-benefit profile., Determined by the investigator to be medically stable at the final visit of BHV4157-302 or BHV4157-303, (the labs collected at the Week 10 visit for BHV4157-302 or BHV4157-303), as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing., Women of child bearing potential (WOCBP) and fertile men (including those vasectomized for less than 6 months) with female partners who are WOCBP (not having undergone bilateral tubal occlusion procedure and not post- menopausal) must agree to use highly effective birth control, including two methods of contraception, for the duration of the study.
Subjects who did not successfully complete randomization phase in BHV4157-302/BHV4157-303 study., Acute suicidality or suicide attempt or self injurious behavior in last 12 months., Patients who plan to receive non-biological or biological investigational agent in while enrolled in trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method