Long-Term Safety of Troriluzole for OCD

Recruiting at 175 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Biohaven Pharmaceuticals, Inc.

Disqualifiers: Acute suicidality, Self injurious behavior, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 240 weeks

1200 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It seems likely that you can continue your existing treatment since the study is evaluating an additional therapy for 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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 200 mg daily of Troriluzole for the first 2 weeks, followed by 280 mg daily

240 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Troriluzole

Trial Overview 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.

Participant Groups

Group I: Troriluzole (BHV-4157) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Biohaven Pharmaceuticals, Inc.

Lead Sponsor

Trials

49

Recruited

30,100+