Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder
Purpose
The purpose of the study is to evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with obsessive compulsive disorder (OCD).
Condition
- Obsessive Compulsive Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Eligible subjects are those 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 week 10 visit of BHV4157-302 or BHV4157-303, as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. - It is required that all women of child-bearing potential (WOCBP) who are sexually active agree to use two methods of contraception for the duration of the study
Exclusion Criteria
- Subjects who did not successfully complete 10 weeks of treatment in the BHV4157-302 or BHV4157-303 study. - Acute suicidality or suicide attempt or self injurious behavior in the last 12 months. - Patients who may have received a non-biological investigational agent in any clinical trial within 30 days or a biological agent within 90 days prior to entry, other than what was received in BHV4157-302 or BHV4157-303;
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Troriluzole (BHV-4157) |
200 mg daily first 2 weeks, 280 daily following first 2 weeks |
|
More Details
- Status
- Terminated
- Sponsor
- Biohaven Pharmaceuticals, Inc.