What is the mechanism of action of this treatment?

The most common treatments for Obsessive-Compulsive Disorder (OCD) primarily involve the modulation of neurotransmitters, particularly serotonin and glutamate. Selective serotonin reuptake inhibitors (SSRIs) increase serotonin levels in the brain, which helps reduce OCD symptoms by enhancing mood and reducing anxiety. Troriluzole, an investigational drug, modulates glutamate levels, aiming to balance excessive glutamate activity that is thought to contribute to OCD symptoms. Understanding these mechanisms is crucial for OCD patients as it helps tailor treatments to their specific neurochemical imbalances, potentially improving efficacy and reducing side effects.

What side effects are associated with this type of intervention?

Common treatments for Obsessive-Compulsive Disorder (OCD) include serotonin reuptake inhibitors (SRIs) and cognitive-behavioral therapy (CBT). SRIs, such as fluoxetine and sertraline, can cause side effects like nausea, insomnia, sexual dysfunction, and weight gain. For treatments modulating glutamate levels, such as topiramate and ketamine, side effects may include cognitive impairment, dizziness, fatigue, and in the case of ketamine, potential for abuse and dissociative symptoms. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Obsessive-Compulsive Disorder (OCD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, fluvoxamine, paroxetine, and sertraline, as well as the tricyclic antidepressant clomipramine. These medications primarily work by increasing serotonin levels in the brain. While Troriluzole, which modulates glutamate levels, is still under investigation, riluzole is another drug that has been studied for its potential in OCD treatment due to its glutamate-modulating properties. However, riluzole has not received FDA approval specifically for OCD.

What other types of research exist?

Promising novel alternatives to Troriluzole for OCD treatment include ketamine, which has shown rapid and robust clinical effects in OCD patients, and LY341495, an mGlu2/3 receptor antagonist that has demonstrated potential in alleviating depressive-like behaviors in animal models. Both treatments modulate glutamate levels and have shown efficacy in related conditions.

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Long-Term Safety of Troriluzole for OCD

Phase 3

Waitlist Available

Research Sponsored by Biohaven Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

It is required that all women of child-bearing potential (WOCBP) who are sexually active agree to use two methods of contraception for the duration of the study

Key

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to week 48

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, 'tolerability' suggests monitoring for any adverse reactions patients might experience while taking Troriluzole over a long duration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am unsure what 'Key' refers to in this context.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clomipramine

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

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

200 mg daily first 2 weeks, 280 daily for following 46 weeks

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Obsessive-Compulsive Disorder (OCD) primarily involve the modulation of neurotransmitters, particularly serotonin and glutamate. Selective serotonin reuptake inhibitors (SSRIs) increase serotonin levels in the brain, which helps reduce OCD symptoms by enhancing mood and reducing anxiety. Troriluzole, an investigational drug, modulates glutamate levels, aiming to balance excessive glutamate activity that is thought to contribute to OCD symptoms. Understanding these mechanisms is crucial for OCD patients as it helps tailor treatments to their specific neurochemical imbalances, potentially improving efficacy and reducing side effects.

Glutamatergic drugs exacerbate symptomatic behavior in a transgenic model of comorbid Tourette's syndrome and obsessive-compulsive disorder.