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

Compensation: Varies

Number of Visits: 5

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if troriluzole can help people with Obsessive-Compulsive Disorder (OCD) when added to their usual medication. Researchers are comparing troriluzole to a placebo (a pill with no active medicine) to test its effectiveness and safety. The trial seeks participants who have had OCD for over a year and have not found sufficient relief from their current medication. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for OCD.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that troriluzole is under careful study to determine its safety and effectiveness in treating Obsessive Compulsive Disorder (OCD). In earlier studies, most participants taking troriluzole did not experience serious side effects. The common side effects were usually mild, such as headaches and dizziness.

Since this trial is in a later stage, earlier studies have already demonstrated that troriluzole is safe enough for continued testing. This provides researchers with confidence in its safety to study it with more people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for OCD?

Unlike the standard treatments for obsessive-compulsive disorder (OCD), which often include SSRIs like fluoxetine or cognitive-behavioral therapies, Troriluzole works by modulating glutamate, a key neurotransmitter in the brain. This unique mechanism of action could potentially offer relief for those who don't respond well to current options. Researchers are excited about Troriluzole because it targets brain chemistry in a novel way, offering hope for improved outcomes in managing OCD symptoms.

What evidence suggests that troriluzole might be an effective treatment for OCD?

This trial will compare the effects of Troriluzole with a placebo in individuals with Obsessive-Compulsive Disorder (OCD). Research has shown that Troriluzole might benefit people with OCD who do not find enough relief from standard treatments. In one study, patients taking Troriluzole showed steady improvement in their OCD symptoms compared to those taking a placebo, which contains no active medicine. Another study found that adding Troriluzole to regular OCD treatments helped patients who had not fully improved with those treatments alone. These findings suggest that Troriluzole could be a useful addition to current OCD therapies. Research continues, but early results are promising for those dealing with OCD. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03299166

Troriluzole (BHV-4157) in Adult Participants With ... The purpose of this study is to evaluate the efficacy of troriluzole as adjunctive therapy versus placebo in participants with obsessive compulsive disorder ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04708834

Long-term Safety Study of Adjunctive Troriluzole in ... The purpose of the study is to evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with obsessive compulsive ...

3. prnewswire.com prnewswire.com/news-releases/biohaven-announces-obsessive-compulsive-disorder-ocd-proof-of-concept-phase-23-study-results-and-program-update-301082586.html

Biohaven Announces Obsessive-Compulsive Disorder ... Troriluzole 200 mg administered once daily as adjunctive therapy in OCD patients with inadequate response to standard of care treatment showed consistent ...

4. withpower.com withpower.com/trial/phase-3-disease-11-2020-6284b

Troriluzole for Obsessive-Compulsive Disorder This trial is for individuals with Obsessive-Compulsive Disorder (OCD) who haven't had enough improvement with standard treatments like certain antidepressants.

5. biohaven.com biohaven.com/wp-content/uploads/ASCP-2024-poster-troriluzole-OCD.pdf

ASCP-2024-poster-troriluzole-OCD.pdf A Phase 2 study of troriluzole in OCD demonstrated consistent treatment benefit at all timepoints. Patients with more severe OCD symptoms at.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04641143/efficacy-and-safety-study-of-adjunctive-troriluzole-in-obsessive-compulsive-disorder

Efficacy and Safety Study of Adjunctive Troriluzole in ... The study's purpose is to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive ...

7. ctv.veeva.com ctv.veeva.com/study/efficacy-and-safety-study-of-adjunctive-troriluzole-in-obsessive-compulsive-disorder

Efficacy and Safety Study of Adjunctive Troriluzole in ... The study's purpose is to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with ...