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Adjunctive Troriluzole for OCD

Phase 3
Recruiting
Research Sponsored by Biohaven Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are you b/t the ages of 18-65 years old?
Are you currently on a medication for your mental health?
Must not have
Current or prior history of: bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autism spectrum disorders, borderline personality disorder, antisocial personality disorder, Tourette's disorder, body dysmorphic disorder, hoarding disorder, or psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT); or general medical condition that may confound safety and/or efficacy results.
Timeline
Screening 1 day
Treatment Varies
Follow Up 3 days
Awards & highlights

Summary

This trial is testing a new medication called troriluzole to see if it helps people with OCD who aren't getting enough relief from their current treatments. Troriluzole is added to their existing medications and works by changing brain chemicals to reduce OCD symptoms. Troriluzole is related to riluzole, which has shown benefits in treating OCD when used alongside existing treatments.

Who is the study for?
This trial is for adults with Obsessive Compulsive Disorder (OCD) who haven't had enough improvement with standard treatments like certain antidepressants. They should be medically stable and able to complete the study, without a history of severe mental health disorders or brain injuries.
What is being tested?
The trial is testing Troriluzole as an added treatment against a placebo in people with OCD. The goal is to see if it's effective and safe when used alongside current medications that aren't working well enough.
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions to Troriluzole compared to those taking the placebo.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
You have a history of certain mental health disorders or treatments that may impact the study's safety and effectiveness.

Timeline

Screening ~ 1 day
Treatment ~ Varies
Follow Up ~3 days
This trial's timeline: 1 day for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The total score on the Yale-Brown Obsessive Compulsive Disorder (YBOCS)
Secondary study objectives
Frequency of SAEs and AEs leading discontinuation
Improvement in function disability as assessed by the change in the Sheehan Disability Scale (SDS)
Improvement in global functioning responses as assessed on the CGI-I scale.

Side effects data

From 2020 Phase 3 trial • 881 Patients • NCT03829241
9%
Nausea
5%
Fatigue
5%
Upper respiratory tract infection
4%
Headache
3%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
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
Troriluzole- 2 100mg capsules once daily for the first two weeks. Troriluzole- 2 140mg capsules once daily from week two through week ten.
Group II: PlaceboPlacebo Group1 Intervention
Placebo- 2 100mg capsules once daily for the first two weeks. Placebo- 2 140mg capsules once daily from week two through week ten.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Troriluzole
2019
Completed Phase 3
~890

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) include selective serotonin reuptake inhibitors (SSRIs), cognitive-behavioral therapy (CBT), and emerging treatments like glutamate modulators. SSRIs work by increasing serotonin levels in the brain, which helps reduce OCD symptoms by improving mood and anxiety. CBT, particularly exposure and response prevention (ERP), helps patients confront and manage their obsessions and compulsions. Glutamate modulators, such as Troriluzole, aim to regulate glutamate levels, which are believed to be dysregulated in OCD. This is significant because glutamate is a key neurotransmitter involved in neural communication, and its imbalance may contribute to the intrusive thoughts and repetitive behaviors characteristic of OCD. Understanding these mechanisms is crucial for tailoring effective treatment plans and improving patient outcomes.
Glutamatergic drugs exacerbate symptomatic behavior in a transgenic model of comorbid Tourette's syndrome and obsessive-compulsive disorder.

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Biohaven Pharmaceuticals, Inc.Lead Sponsor
48 Previous Clinical Trials
36,623 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
2,326 Patients Enrolled for Obsessive-Compulsive Disorder

Media Library

Troriluzole 2023 Treatment Timeline for Medical Study. Trial Name: NCT04693351 — Phase 3
Obsessive-Compulsive Disorder Patient Testimony for trial: Trial Name: NCT04693351 — Phase 3
~153 spots leftby Sep 2025
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