Long-Term Safety of Troriluzole for OCD

Enrolling by invitation at 177 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the long-term safety of troriluzole for individuals with obsessive-compulsive disorder (OCD). The goal is to assess how well participants tolerate this treatment alongside their existing OCD therapy. Participants who recently completed a related OCD study and are deemed stable by their doctors might be eligible. Those with OCD who participated in earlier studies may find this trial suitable. As a Phase 3 trial, it represents the final step before potential FDA approval, providing an opportunity to contribute to the validation of a promising treatment.

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.

Is there any evidence suggesting that troriluzole is likely to be safe for humans?

Research has shown that troriluzole has undergone safety testing in several studies. In one study, patients used troriluzole for an extended period to assess their tolerance. The results indicated that most participants tolerated it well, experiencing only mild to moderate side effects such as headaches and dizziness, which are common with many medications.

The current study is in a later phase, indicating that earlier trials found the treatment safe enough for testing on a larger group. This is encouraging for potential participants, as it suggests a strong safety record so far. However, discussing potential risks and benefits with a healthcare provider before participating is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for OCD?

Troriluzole is unique because it targets glutamate, a neurotransmitter in the brain, in a novel way that other OCD treatments do not. While standard treatments for OCD, like SSRIs and cognitive-behavioral therapy, focus on serotonin reuptake or behavioral changes, Troriluzole aims to regulate the balance of glutamate, potentially reducing OCD symptoms more effectively. Researchers are excited about Troriluzole because it offers a new approach to managing OCD, which could be particularly beneficial for patients who don't respond to conventional treatments.

What evidence suggests that troriluzole might be an effective treatment for OCD?

Studies have shown that troriluzole can help people with obsessive-compulsive disorder (OCD) who haven't improved enough with standard treatments. Research indicates that patients taking troriluzole experience consistent benefits over time. In one study, even those with more severe OCD symptoms improved. Troriluzole likely works by affecting the brain's glutamate system, which plays a role in OCD. These findings suggest that troriluzole may be a promising option for managing OCD symptoms. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03299166

Troriluzole (BHV-4157) in Adult Participants With ... The purpose of this study is to evaluate the efficacy of troriluzole as adjunctive therapy versus placebo in participants with obsessive compulsive disorder ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04708834

Long-term Safety Study of Adjunctive Troriluzole in ... The purpose of the study is to evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with obsessive compulsive ...

3. prnewswire.com prnewswire.com/news-releases/biohaven-announces-obsessive-compulsive-disorder-ocd-proof-of-concept-phase-23-study-results-and-program-update-301082586.html

Biohaven Announces Obsessive-Compulsive Disorder ... Troriluzole 200 mg administered once daily as adjunctive therapy in OCD patients with inadequate response to standard of care treatment showed consistent ...

4. biohaven.com biohaven.com/wp-content/uploads/ASCP-2024-poster-troriluzole-OCD.pdf

ASCP-2024-poster-troriluzole-OCD.pdf A Phase 2 study of troriluzole in OCD demonstrated consistent treatment benefit at all timepoints. Patients with more severe OCD symptoms at.

5. withpower.com withpower.com/trial/phase-3-disease-11-2020-6284b

Troriluzole for Obsessive-Compulsive Disorder This trial is for individuals with Obsessive-Compulsive Disorder (OCD) who haven't had enough improvement with standard treatments like certain antidepressants.

6. ctv.veeva.com ctv.veeva.com/study/long-term-safety-study-of-adjunctive-troriluzole-in-subjects-with-obsessive-compulsive-disorder

Long-term Safety Study of Adjunctive Troriluzole in Subjects ... The purpose of the study is to evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with obsessive ...

7. onderzoekmetmensen.nl onderzoekmetmensen.nl/en/node/52032/pdf

A Multicenter, Long-Term Open-Label Safety Study of ... The primary objective of the study is to evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with ...

8. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/trial/2020-004654-30/IT

Clinical Trials Register A Multicenter, 48-week Open-Label Safety Study of Adjunctive Troriluzole in Subjects with Obsessive Compulsive Disorder.