Troriluzole for Obsessive-Compulsive Disorder

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

426 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing troriluzole to see if it can help people with OCD who haven't improved with common medications. Troriluzole works by balancing brain chemicals that may be causing OCD symptoms. The goal is to find a more effective treatment for those who need additional help.

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.

What evidence supports the effectiveness of the drug Troriluzole for treating Obsessive-Compulsive Disorder?

Some studies suggest that riluzole, a component of Troriluzole, may help people with OCD who don't respond to standard treatments. It works by affecting glutamate, a chemical in the brain, and has shown potential benefits in small trials when added to other OCD medications. ^{1 2 3 4 5}

Is Troriluzole (BHV-4157) safe for humans?

Riluzole, a similar drug to Troriluzole, was generally well tolerated in a study with children, though there was one case of pancreatitis (inflammation of the pancreas) and some slight increases in liver enzymes. This suggests that while it is mostly safe, there can be some serious side effects. ^{1 6 7 8 9}

How is the drug Troriluzole different from other OCD treatments?

Troriluzole, also known as BHV-4157, is unique because it modulates glutamate, a brain chemical involved in OCD, whereas most traditional OCD treatments focus on serotonin. This approach is based on evidence suggesting glutamate dysfunction in OCD, offering a novel mechanism compared to standard serotonin-based therapies. ^{1 4 5 10 11}

Eligibility Criteria

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.

I have at least 6 years of education and am fluent in English.

My health is stable based on recent exams and tests.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Riluzole in augmentation of fluvoxamine for moderate to severe obsessive-compulsive disorder: Randomized, double-blind, placebo-controlled study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Riluzole augmentation in treatment-refractory obsessive-compulsive disorder: a pilot randomized placebo-controlled trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Lamotrigine as an augmentation agent in treatment-resistant obsessive-compulsive disorder: a case report. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Obsessive-compulsive disorder: treatment with serotonin-selective uptake inhibitors, azapirones, and other agents. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

An open-label trial of riluzole, a glutamate antagonist, in children with treatment-resistant obsessive-compulsive disorder. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Lamotrigine augmentation of serotonin reuptake inhibitors in severe and long-term treatment-resistant obsessive-compulsive disorder. [2021]

7. France pubmed.ncbi.nlm.nih.gov

[Pharmacologic treatment of obsessive compulsive disorder in the child and adolescent]. [2022]

8. England pubmed.ncbi.nlm.nih.gov

12-week, placebo-controlled trial of add-on riluzole in the treatment of childhood-onset obsessive-compulsive disorder. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Genetic findings in obsessive-compulsive disorder connect to brain-derived neutrophic factor and mammalian target of rapamycin pathways: implications for drug development. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Riluzole augmentation in treatment-resistant obsessive-compulsive disorder: an open-label trial. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Lack of efficacy of clozapine monotherapy in refractory obsessive-compulsive disorder. [2013]