What side effects are associated with this type of intervention?

Common treatments for OCD that involve glutamate modulation, such as memantine and other glutamatergic agents, have been associated with various side effects. Memantine treatment can lead to adverse effects like dizziness, headache, and confusion. Inositol, another agent, has shown significant reduction in OCD symptoms but lacks detailed side effect data in the provided context. Celecoxib, when used adjunctively with SSRIs, has shown significant improvement in OCD symptoms but can cause gastrointestinal issues and increased risk of cardiovascular events. Overall, while glutamatergic agents are effective, they carry risks of adverse effects such as dizziness, gastrointestinal discomfort, and potential cardiovascular issues.

What prior FDA approvals exist?

The FDA has approved several selective serotonin reuptake inhibitors (SSRIs) for the treatment of Obsessive-Compulsive Disorder (OCD), including fluoxetine, fluvoxamine, paroxetine, and sertraline. Clomipramine, a tricyclic antidepressant, is also approved for OCD. These medications primarily work by modulating serotonin levels. While the provided context does not mention specific FDA approvals for glutamate modulation in OCD, it does reference ongoing studies like the one on troriluzole, which is being evaluated for its efficacy and safety as an adjunctive therapy in OCD. This suggests a growing interest in exploring glutamate modulation as a potential treatment pathway for OCD.

What other types of research exist?

Promising novel alternatives to Troriluzole for OCD treatment include mGlu4 allosteric modulators, such as ADX88178, which have shown potential in preclinical models for anxiety, OCD, and related disorders. Additionally, agents targeting AMPA receptors and NR2B receptor antagonists may also be useful in treating OCD.

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Troriluzole for Obsessive-Compulsive Disorder

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

An inadequate response to current Standard of Care medication defined as selective serotonin reuptake inhibitor (excluding fluvoxamine) or clomipramine treatment at an adequate and stable dose for at least 8 weeks prior to screening and at least 12 weeks at baseline (adequate dose defined by USPI labeling); an inadequate response as defined per the MGH-TRQ-OCD, there has been minimal or no meaningful clinical benefit as perceived by the subject

Determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Subjects must be physically able and expected to complete the trial as designed

Timeline

Screening 21 days

Treatment 12 weeks

Follow Up 2 weeks

Awards & highlights

Pivotal Trial

Summary

This trial is testing troriluzole as an extra treatment for people with OCD. It aims to see if the medication can help by balancing brain chemicals, making other treatments work better.

Who is the study for?

This trial is for individuals with Obsessive-Compulsive Disorder (OCD) who haven't had enough improvement with standard treatments like certain antidepressants. They should have been on a stable dose for at least 12 weeks and be in good health overall, without serious psychiatric or medical conditions that could interfere with the study.

What is being tested?

The trial is testing troriluzole as an additional treatment to see if it's more effective than a placebo (a pill with no active drug). Participants will either receive troriluzole or the placebo alongside their current OCD medication.

What are the potential side effects?

While specific side effects of troriluzole are not listed here, common side effects from similar medications may include nausea, headache, dizziness, and fatigue. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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You have been diagnosed with obsessive-compulsive disorder (OCD) for at least one year, as confirmed by a medical evaluation.

Timeline

Screening ~ 21 days1 visit

Treatment ~ 12 weeks6 visits

Follow Up ~ 2 weeks1 visit

Screening ~ 21 days

Treatment ~ 12 weeks

Follow Up ~2 weeks

This trial's timeline: 21 days for screening, 12 weeks for treatment, and 2 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

The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS)

Secondary study objectives

Frequency of SAEs and AEs leading to discontinuation

Improvement in functional disability as assessed by the change in Sheehan Disability Scale (SDS)

Improvement in global functioning responses assessed on the CGI-I scale.

Awards & Highlights

Pivotal Trial

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

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: TroriluzoleActive Control1 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.

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) include serotonin reuptake inhibitors (SRIs), cognitive-behavioral therapy (CBT), and emerging treatments like glutamate modulators. SRIs, such as fluoxetine and sertraline, work by increasing serotonin levels in the brain, which can help reduce OCD symptoms. CBT, particularly exposure and response prevention (ERP), helps patients confront and manage their obsessions and compulsions through structured behavioral techniques. Glutamate modulators, like Troriluzole, target the glutamatergic system, which is involved in the corticostriatal thalamocortical circuitry implicated in OCD. This approach aims to balance glutamate levels, potentially offering relief for patients who do not respond to traditional treatments. Understanding these mechanisms is crucial for patients, as it highlights the different pathways through which OCD symptoms can be managed, allowing for more personalized and effective treatment plans.

Animal models of obsessive compulsive disorder: recent findings and future directions.Glutamatergic drugs exacerbate symptomatic behavior in a transgenic model of comorbid Tourette's syndrome and obsessive-compulsive disorder.