A Multicenter, Long-Term Open-Label Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder

BHV4157-209

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).

2021-03-30

2025-06-01

2025-06-01

Early phase I

1200

Key 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 Key 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;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1200, 'type': 'ESTIMATED'}}

2023-11-18