Long-Term Safety of Troriluzole for OCD

Recruiting in Palo Alto (17 mi)

+175 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Biohaven Pharmaceuticals, Inc.

Stay on your current meds

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing the safety and tolerability of troriluzole as an additional treatment for people with OCD. Troriluzole may help balance brain chemicals to reduce OCD symptoms. Troriluzole is related to riluzole, which has been studied for its potential benefits in treating anxiety disorders and OCD.

Eligibility Criteria

This trial is for individuals who have completed previous studies BHV4157-302 or BHV4157-303, are medically stable, and if capable of childbearing, agree to use two contraception methods. It's not for those with recent suicidality or participation in other drug trials within specified time frames.

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.

My doctor considers me medically stable based on recent tests and exams.

I agree to use two forms of birth control during the study.

+4 more

Exclusion Criteria

You have attempted suicide, engaged in self-harm, or had suicidal thoughts in the past year.

Subjects who did not successfully complete 10 weeks of treatment in the BHV4157-302 or BHV4157-303 study.

You cannot have participated in another clinical trial involving a non-approved medication within 30 days, or a clinical trial involving a biological medication within the past 90 days, except for the BHV4157-302 or BHV4157-303 trials.

Participant Groups

The study tests the long-term safety of Troriluzole as an additional treatment for OCD. Participants will continue from prior studies to assess how well they tolerate this medication over a more extended period.

1Treatment groups

Experimental Treatment

Group I: Troriluzole (BHV-4157)Experimental Treatment1 Intervention

200 mg daily first 2 weeks, 280 daily following first 2 weeks