What side effects are associated with this type of intervention?

Common treatments for Obsessive-Compulsive Disorder (OCD) include SSRIs and glutamatergic agents like topiramate, lamotrigine, and ketamine. SSRIs can cause side effects such as nausea, insomnia, sexual dysfunction, and weight gain. Topiramate may lead to adverse effects like cognitive impairment, weight loss, and paresthesia. Lamotrigine is generally well-tolerated but can cause rash, dizziness, and headache. Ketamine, used off-label, can result in dizziness, impaired gait, nasal discomfort, and in some cases, pain on urination. These side effects should be carefully considered when choosing a treatment plan.

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 treatment. These medications primarily work by modulating serotonin levels. While the context does not provide specific information on FDA-approved treatments involving glutamate modulation similar to troriluzole, it is noted that various augmentation strategies, including those targeting different neurotransmitter systems, are being explored for treatment-resistant OCD.

What other types of research exist?

Promising novel alternatives to Troriluzole for OCD treatment include adjunctive therapies such as ketamine, which has shown moderate success in reducing severe anxiety, and flumazenil, which has been used to reverse benzodiazepine-induced sedation. Additionally, electroconvulsive therapy (ECT) has been noted for its efficacy in treating major depression and OCD, and may be considered as an alternative treatment option.

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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

Pivotal Trial

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 day7 visits

Treatment ~ Varies

Follow Up ~ 3 days1 visit

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

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

Awards & Highlights

Pivotal Trial

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

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

2016

Completed Phase 3

~1030

0 / 6Eligibility 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 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.