Troriluzole for Obsessive-Compulsive Disorder

Overseen By Chief Medical Officer

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 3

Sponsor: Biohaven Pharmaceuticals, Inc.

Must be taking: SSRIs, Clomipramine

Disqualifiers: Bipolar, Schizophrenia, Autism, others

Stay on Your Current Meds You can continue your current medications while participating

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

1 Power Preferred Clinic 1 of this trial's clinic is considered top 20 on Power

Compensation: Varies

Number of Visits: 5

Duration: 10 weeks

700 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that you have been on a stable dose of a specific OCD medication for at least 12 weeks before starting the trial.

What data supports the effectiveness of the drug Troriluzole for treating obsessive-compulsive disorder?

Research on riluzole, a similar drug that affects glutamate (a brain chemical), shows potential benefits for people with obsessive-compulsive disorder (OCD) who don't respond well to standard treatments. This suggests that Troriluzole, which is related to riluzole, might also help with OCD. ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Have you experienced OCD symptoms for at least one year?

Have you been taking a stable dose of one of these medications: Citalopram, Escitalopram, Fluoxetine, Paroxetine, Sertraline, Clomipramine, Venlafaxine, Desvenlafaxine for at least 8 weeks?

Exclusion Criteria

Have you ever had psychosurgery, Deep Brain Stimulation (DBS), Electroconvulsive Therapy (ECT), or Transcranial Magnetic Stimulation (TMS)?

Do you have a current or prior history of Bipolar Disorder, Schizophrenia, Autism, Borderline Personality Disorder, Antisocial Personality Disorder, or Body Dysmorphic Disorder?

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either Troriluzole or placebo for 10 weeks, with dosage adjustments after the first two weeks

10 weeks

4 visits (in-person) at baseline, week 4, 8, and 10

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• Troriluzole

Trial Overview 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.

Participant Groups

Group I: Troriluzole Active Control 1 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: Placebo Placebo Group 1 Intervention

Placebo - 2 100mg capsules once daily for the first two weeks. Placebo - 2 140mg capsules once daily from week two through week ten.

Who Is Running the Clinical Trial?

Biohaven Pharmaceuticals, Inc.

Lead Sponsor

Trials

49

Recruited

30,100+

Findings from Research

In an 8-week randomized trial with 50 patients, adding riluzole to fluvoxamine treatment significantly improved symptoms of moderate to severe obsessive-compulsive disorder, as measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).

The study found that patients receiving riluzole showed a greater reduction in both total Y-BOCS scores and the Compulsive subscale scores compared to those receiving fluvoxamine plus placebo, indicating that riluzole may enhance the efficacy of fluvoxamine in treating OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Riluzole in augmentation of fluvoxamine for moderate to severe obsessive-compulsive disorder: Randomized, double-blind, placebo-controlled study. Emamzadehfard, S., Kamaloo, A., Paydary, K., et al.[2022]

In a 12-week open-label trial involving 6 children aged 8-16 with treatment-resistant OCD, 4 out of 6 subjects showed significant improvement in symptoms, with a reduction of over 46% on the Children's Yale-Brown Obsessive-Compulsive Scale.

Riluzole was well tolerated, with no adverse effects leading to discontinuation, and all participants chose to continue the medication after the trial, suggesting its potential as a safe alternative treatment for OCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open-label trial of riluzole, a glutamate antagonist, in children with treatment-resistant obsessive-compulsive disorder. Grant, P., Lougee, L., Hirschtritt, M., et al.[2022]

In a pilot study involving 38 patients with obsessive-compulsive disorder (OCD) who were not responding well to standard serotonin reuptake inhibitors (SRIs), riluzole was found to be well tolerated with minimal side effects, suggesting it is a safe option for augmentation therapy.

While the overall improvement in OCD symptoms with riluzole did not reach statistical significance, there was a notable trend indicating potential benefits, particularly in outpatients, where more patients experienced at least a 25% improvement compared to those on placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Riluzole augmentation in treatment-refractory obsessive-compulsive disorder: a pilot randomized placebo-controlled trial. Pittenger, C., Bloch, MH., Wasylink, S., et al.[2022]

In a study of 13 patients with treatment-resistant obsessive-compulsive disorder (OCD), the addition of riluzole significantly improved OCD symptoms, with 54% of participants showing over a 35% reduction in their Yale-Brown Obsessive Compulsive Scale (Y-BOCS) scores.

Riluzole was well tolerated and also led to significant improvements in depression and anxiety symptoms, suggesting it could be a beneficial augmentation therapy for patients who do not respond fully to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Riluzole augmentation in treatment-resistant obsessive-compulsive disorder: an open-label trial. Coric, V., Taskiran, S., Pittenger, C., et al.[2013]

In a 10-week double-blind, placebo-controlled trial involving 27 outpatients with obsessive-compulsive disorder, clomipramine was found to be significantly more effective than a placebo.

This study supports the efficacy of clomipramine as a treatment option for individuals diagnosed with obsessive-compulsive disorder according to DSM-III-R criteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obsessive-compulsive disorder: a double-blind, placebo-controlled trial of clomipramine in 27 patients. Jenike, MA., Baer, L., Summergrad, P., et al.[2013]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Riluzole in augmentation of fluvoxamine for moderate to severe obsessive-compulsive disorder: Randomized, double-blind, placebo-controlled study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

An open-label trial of riluzole, a glutamate antagonist, in children with treatment-resistant obsessive-compulsive disorder. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Riluzole augmentation in treatment-refractory obsessive-compulsive disorder: a pilot randomized placebo-controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Riluzole augmentation in treatment-resistant obsessive-compulsive disorder: an open-label trial. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Obsessive-compulsive disorder: a double-blind, placebo-controlled trial of clomipramine in 27 patients. [2013]