Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder

• Status: Enrolling by invitation
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biohaven Pharmaceuticals, Inc.

Criteria

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;