Troriluzole for Obsessive-Compulsive Disorder

Not currently recruiting at 56 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Biohaven Pharmaceuticals, Inc.

Must be taking: SSRIs, Clomipramine, Venlafaxine

Disqualifiers: Bipolar, Schizophrenia, Eating disorders, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether troriluzole, a new medication, can aid individuals with obsessive-compulsive disorder (OCD) who haven't found sufficient success with current treatments like SSRIs, clomipramine, or venlafaxine. Participants will receive either troriluzole (also known as BHV-4157) or a placebo to determine the drug's effectiveness. The trial seeks individuals who have had OCD for at least a year and currently experience moderate to severe symptoms despite other medications. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking OCD treatment advancements.

Do I need to stop my current medications to join the trial?

No, you do not need to stop your current medications. In fact, you must continue taking your current SSRI, clomipramine, venlafaxine, or desvenlafaxine as part of the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that troriluzole is generally well-tolerated and has a good safety record. It is designed to be gentle on the liver by avoiding "first-pass metabolism," a process that can strain the liver.

In a large study with 1,386 participants, including those with obsessive-compulsive disorder (OCD), researchers found troriluzole to be safe. Long-term studies have also examined its safety over time, which is crucial for understanding how people respond to the treatment in the long run. Overall, troriluzole appears to be a safe option for those considering joining a trial. ^{1 2 3 4 5}

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

Unlike the standard treatments for obsessive-compulsive disorder (OCD), which often include selective serotonin reuptake inhibitors (SSRIs) and cognitive behavioral therapy (CBT), Troriluzole works differently by modulating glutamate levels in the brain. Researchers are excited about Troriluzole because it targets the glutamatergic system, offering a novel mechanism of action that could benefit patients who don't respond to traditional therapies. This new approach has the potential to address unmet needs in OCD treatment, providing hope for better outcomes.

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

Research has shown that troriluzole, which participants in this trial may receive, may help treat obsessive-compulsive disorder (OCD), particularly in individuals with more severe symptoms. In earlier studies, patients taking troriluzole experienced a noticeable reduction in their OCD symptoms, improving by an average of 5.1 points on a scale measuring OCD severity, compared to a 3.6-point improvement in those taking a placebo. This scale is commonly used to assess OCD symptom severity. The evidence suggests that troriluzole could be a helpful additional treatment for those who don't find enough relief from current medications like SSRIs or clomipramine. These results strongly indicate that troriluzole may effectively reduce OCD symptoms. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adults with Obsessive Compulsive Disorder (OCD) who haven't had enough improvement from certain medications like SSRIs or clomipramine. Participants must be medically stable, able to perform tests and interviews, understand English well, and agree to use two forms of contraception if applicable. They should have moderate to severe OCD symptoms despite current treatment but no other major psychiatric conditions that could affect their OCD assessment.

Inclusion Criteria

My current medication for OCD isn't working well, and my symptoms are severe.

My health is stable based on recent exams and tests.

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

Exclusion Criteria

Mini Mental State Examination (MMSE) score of < 24 at Screening

I do not have any mental or physical health conditions that could explain my OCD symptoms.

I have tried at least 3 different depression medications without success.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either troriluzole or placebo as adjunctive therapy for OCD

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may continue to receive troriluzole in an open-label extension phase

96 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BHV-4157
• Placebo

Trial Overview The study is testing the effectiveness of troriluzole as an additional treatment compared to a placebo in people with OCD who don’t respond well enough to standard treatments. Troriluzole's benefits will be evaluated alongside participants' ongoing medication regimens.

How Is the Trial Designed?

Group I: Troriluzole Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Biohaven Pharmaceuticals, Inc.

Lead Sponsor

Trials

49

Recruited

30,100+

Published Research Related to This Trial

In a 12-week open-label trial involving 6 children aged 8-16 with treatment-resistant OCD, 4 out of 6 subjects showed significant improvement in symptoms, with a reduction of over 46% on the Children's Yale-Brown Obsessive-Compulsive Scale.

Riluzole was well tolerated, with no adverse effects leading to discontinuation, and all participants chose to continue the medication after the trial, suggesting its potential as a safe alternative treatment for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open-label trial of riluzole, a glutamate antagonist, in children with treatment-resistant obsessive-compulsive disorder. Grant, P., Lougee, L., Hirschtritt, M., et al.[2022]

In a study of 13 patients with treatment-resistant obsessive-compulsive disorder (OCD), the addition of riluzole significantly improved OCD symptoms, with 54% of participants showing over a 35% reduction in their Yale-Brown Obsessive Compulsive Scale (Y-BOCS) scores.

Riluzole was well tolerated and also led to significant improvements in depression and anxiety symptoms, suggesting it could be a beneficial augmentation therapy for patients who do not respond fully to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Riluzole augmentation in treatment-resistant obsessive-compulsive disorder: an open-label trial. Coric, V., Taskiran, S., Pittenger, C., et al.[2013]

In a pilot study involving 38 patients with obsessive-compulsive disorder (OCD) who were not responding well to standard serotonin reuptake inhibitors (SRIs), riluzole was found to be well tolerated with minimal side effects, suggesting it is a safe option for augmentation therapy.

While the overall improvement in OCD symptoms with riluzole did not reach statistical significance, there was a notable trend indicating potential benefits, particularly in outpatients, where more patients experienced at least a 25% improvement compared to those on placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Riluzole augmentation in treatment-refractory obsessive-compulsive disorder: a pilot randomized placebo-controlled trial. Pittenger, C., Bloch, MH., Wasylink, S., et al.[2022]

In an 8-week randomized trial with 50 patients, adding riluzole to fluvoxamine treatment significantly improved symptoms of moderate to severe obsessive-compulsive disorder, as measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).

The study found that patients receiving riluzole showed a greater reduction in both total Y-BOCS scores and the Compulsive subscale scores compared to those receiving fluvoxamine plus placebo, indicating that riluzole may enhance the efficacy of fluvoxamine in treating OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Riluzole in augmentation of fluvoxamine for moderate to severe obsessive-compulsive disorder: Randomized, double-blind, placebo-controlled study. Emamzadehfard, S., Kamaloo, A., Paydary, K., et al.[2022]

Obsessive-compulsive disorder (OCD) affects about 1 in 40 people in the U.S., and recent studies show that it can respond to drug treatments, particularly selective serotonin uptake inhibitors like clomipramine and fluoxetine.

Emerging research suggests that buspirone, which has anxiolytic and potential antidepressant effects, may provide direct benefits for OCD patients or enhance the effects of fluoxetine when used together.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obsessive-compulsive disorder: treatment with serotonin-selective uptake inhibitors, azapirones, and other agents. Murphy, DL., Pato, MT., Pigott, TA.[2013]

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

ASCP-2024-poster-troriluzole-OCD.pdf Patients with more severe OCD symptoms at baseline also demonstrated larger treatment effects. These results informed the development of 2 ...

3. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/66/NCT03299166/SAP_001.pdf

TITLE: A Randomized, Double-Blind, Placebo-Controlled ... Treatment group comparison at Week 12 will be based on least square mean. (LSMean) difference between Troriluzole and placebo estimated by the analysis model in ...

4. 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 treated subjects had a mean Y-BOCS improvement of -5.1 points from baseline versus -3.6 for placebo-treated subjects [difference - ...

5. ctv.veeva.com ctv.veeva.com/study/troriluzole-bhv-4157-in-adult-participants-with-obsessive-compulsive-disorder

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

6. 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 ...

7. biohaven.com biohaven.com/wp-content/uploads/BioH-TRO-HepaticSafety-POS-AAN-Final_4-12-24.pdf

Troriluzole Exhibits Favorable Hepatic Safety Profile ... This large (N = 1386) database of clinical trial safety data, including data on participants with obsessive compulsive disorder, Alzheimer ...

8. neurology.org neurology.org/doi/10.1212/WNL.0000000000206182

Troriluzole Exhibits Favorable Hepatic Safety Profile ... Troriluzole bypasses first-pass metabolism reducing riluzole burden on the liver and is expected to have a superior hepatic safety profile.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT04641143

NCT04641143 | Efficacy and Safety Study of Adjunctive ... The study's purpose is to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive ...

10. 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 ...