What side effects are associated with this type of intervention?

Common treatments for OCD, such as SSRIs (e.g., sertraline, fluvoxamine), clomipramine, and glutamatergic agents like topiramate and lamotrigine, have various side effects. SSRIs can cause nausea, insomnia, sexual dysfunction, and weight gain. Clomipramine may lead to dry mouth, constipation, and dizziness. Glutamatergic agents like topiramate can cause cognitive impairment, weight loss, and paresthesia, while lamotrigine may result in rash, dizziness, and headache. These side effects should be carefully monitored by healthcare providers.

What prior FDA approvals exist?

The primary FDA-approved treatments for Obsessive-Compulsive Disorder (OCD) include 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 focuses on glutamate modulation, is being studied as an adjunctive therapy for OCD, it is not yet FDA-approved for this condition.

What other types of research exist?

Promising alternatives to Troriluzole for OCD treatment include selective serotonin reuptake inhibitors (SSRIs) like fluoxetine and adjunctive therapies such as pitolisant, which has shown efficacy in other psychiatric conditions. Electroconvulsive therapy (ECT) may also be considered for treatment-resistant cases.

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Troriluzole for Obsessive-Compulsive Disorder

Phase 2 & 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

Currently experiencing non-response or inadequate response to current standard of care (SOC) medication with a Yale-Brown Obsessive Compulsive Scale total score ≥ 19 at screening and Baseline

Minimum of 6 years of education or equivalent and sufficiently fluent in English

Must not have

History of psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT)

History of more than 2 previous failed treatment trials of SSRIs, clomipramine, venlafaxine, or desvenlafaxine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 96 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects for troriluzole are not listed here, similar medications can cause nausea, headache, dizziness, fatigue, sleep disturbances and may interact with other drugs. Any new or unusual symptoms experienced during the trial should be reported.

Eligibility Criteria

Inclusion Criteria

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

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

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

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My health is stable based on recent exams and tests.

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

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I have been diagnosed with OCD according to DSM-5.

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I can hear, see, and communicate well enough to undergo tests and interviews.

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

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I am currently taking an SSRI, clomipramine, venlafaxine, or desvenlafaxine.

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I have had OCD for at least a year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had psychosurgery, DBS, or ECT.

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

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I have a history of certain mental health conditions like bipolar disorder or schizophrenia.

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I have not had TMS in the last 3 months and am open to it during the study.

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My heart's electrical activity is normal and does not prevent me from joining the study.

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I have been treated with riluzole before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 96 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 96 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 96 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score

Secondary study objectives

Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score

Change From Baseline in Functional Disability Assessed Using the Sheehan Disability Scale (SDS) Total Score

Change From Baseline in the Y-BOCS Obsessions Sub-Scale Score

+3 more

Other study objectives

Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score at Weeks 4 and 8

Side effects data

From 2020 Phase 3 trial • 881 Patients • NCT03829241

Nausea

Fatigue

Upper respiratory tract infection

Headache

Nasopharyngitis

100%

80%

60%

40%

20%

Study treatment Arm

Troriluzole - Randomization Phase

Placebo - Randomization Phase

Troriluzole - Randomization Phase/Troriluzole - Extension Phase

Placebo - Randomization Phase/Troriluzole - Extension Phase

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TroriluzoleExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Troriluzole

2016

Completed Phase 3

~1030

0 / 15Eligibility 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

Common treatments for Obsessive-Compulsive Disorder (OCD) include selective serotonin reuptake inhibitors (SSRIs) and clomipramine, which work by increasing serotonin levels in the brain to help regulate mood and reduce OCD symptoms. Additionally, glutamate modulation, as seen with drugs like troriluzole, aims to balance elevated glutamate levels that contribute to OCD symptoms. These mechanisms are important for OCD patients because they target specific neurotransmitter systems, offering a more effective approach to symptom relief.

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