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Long-Term Safety Study of Troriluzole for Patients with Obsessive Compulsive Disorder Not Responding to SSRI, Clomipramine, Venlafaxine, or Desvenlafaxine

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term safety of a treatment for Obsessive Compulsive Disorder (OCD). The treatment being tested is called Troriluzole, which is taken in the form of a capsule. Troriluzole is being used as an additional therapy for individuals with OCD who have not responded adequately to other medications such as SSRIs, clomipramine, venlafaxine, or desvenlafaxine.

The purpose of the study is to evaluate how safe and tolerable Troriluzole is when used over a long period. Participants in the study will take Troriluzole orally, and the study will monitor their health to ensure the treatment is safe. The study will last for a maximum of 144 weeks, during which participants will be regularly checked for any side effects or health changes.

Throughout the study, researchers will pay close attention to any adverse effects, including serious adverse events, any side effects that lead to stopping the treatment, and any significant changes in laboratory test results. This information will help determine if Troriluzole is a safe option for people with OCD who need additional treatment support.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after completing a previous study, either BHV4157-302 or BHV4157-303. The investigator must determine that participation in this study presents an acceptable risk-benefit profile.
Medical stability is confirmed through a review of medical history, physical examination, laboratory tests, and electrocardiogram results.
Step 2
Medication administration
The medication used in this study is troriluzole, administered in the form of a capsule.
The route of administration is oral. Specific dosage and frequency details are provided by the study team.
Step 3
Safety and tolerability assessment
The primary goal is to evaluate the long-term safety and tolerability of troriluzole as an additional therapy for those with obsessive-compulsive disorder (OCD) who have not responded adequately to certain other treatments.
Safety is assessed by monitoring the frequency of serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, AEs related to the study medication, and any significant laboratory abnormalities.
Step 4
Use of contraception
Women of childbearing potential and fertile men with partners who are women of childbearing potential must agree to use highly effective birth control methods during the study.
This includes using two methods of contraception to ensure safety throughout the study duration.
Step 5
Study duration
The study is expected to continue until May 13, 2026.
Participants are monitored throughout this period to ensure safety and gather data on the medication's effects.

Who can join the trial?

5 criteria

Participants must have completed study BHV4157-302 or BHV4157-303 and the study doctor must believe that continuing with the open-label treatment is safe and beneficial for them.
Participants must be considered medically stable at the last visit of study BHV4157-302 or BHV4157-303. This means their health is steady based on their medical history, physical check-up, lab test results, and heart test (electrocardiogram).
Women who can have children and men who are fertile (including those who had a vasectomy less than 6 months ago) with female partners who can have children must agree to use very effective birth control. This includes using two methods of contraception during the study.
Both male and female participants are eligible for the study.
The study includes participants from vulnerable populations, which means people who might need extra protection or care.

Who cannot join the trial?

8 criteria

Patients who have a medical condition other than Obsessive Compulsive Disorder (OCD) that could interfere with the study.
Patients who have not had an inadequate response to treatments like SSRI (a type of medication for depression and anxiety), clomipramine, venlafaxine, or desvenlafaxine.
Patients who are not within the specified age range for the study.
Patients who are not willing or able to follow the study procedures.
Patients who are pregnant or breastfeeding.
Patients who have a history of substance abuse or dependence.
Patients who have a serious medical condition that could affect their safety or the study results.
Patients who are currently participating in another clinical trial.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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ASST Fatebenefratelli Sacco
Milan, Italy
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Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy
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Bellvitge University Hospital
L'hospitalet De Llobregat, Spain

Trial locations

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Investigated drugs

Troriluzole
is being studied as an additional treatment for people with Obsessive Compulsive Disorder (OCD) who have not responded well to other medications. It is used alongside other treatments to see if it can help improve symptoms and is being tested for its long-term safety and how well people can tolerate it.
SSRIs
(Selective Serotonin Reuptake Inhibitors) are a group of medications commonly used to treat OCD. They work by increasing the levels of serotonin in the brain, which can help improve mood and reduce anxiety.
Clomipramine
is another medication used to treat OCD. It is a type of antidepressant that helps to balance chemicals in the brain, which can help reduce obsessive and compulsive behaviors.
Venlafaxine
is an antidepressant that is sometimes used to treat OCD. It works by affecting the levels of certain chemicals in the brain, which can help improve mood and reduce anxiety.
Desvenlafaxine
is similar to venlafaxine and is used to treat depression and anxiety. It is being studied to see if it can help people with OCD who have not responded well to other treatments.

Troriluzole

What is already known about the treatment

Troriluzole – Troriluzole is administered orally and is currently being studied in clinical trials as an adjunctive treatment for Obsessive Compulsive Disorder (OCD). It is in the investigational stage, with ongoing research to assess its long-term safety and tolerability. The main therapeutic indication for Troriluzole is to help individuals with OCD who have not responded adequately to standard treatments like SSRIs, clomipramine, venlafaxine, or desvenlafaxine. At the molecular level, Troriluzole works by modulating glutamate levels in the brain, which may help in reducing OCD symptoms. It is classified pharmacologically as a glutamate modulator.

Investigated diseases

Obsessive Compulsive Disorder – This is a mental health condition characterized by persistent, unwanted thoughts (obsessions) and repetitive behaviors or mental acts (compulsions) that an individual feels driven to perform. The obsessions often cause significant anxiety or distress, and the compulsions are aimed at reducing this anxiety or preventing a feared event or situation. Over time, the compulsions can become time-consuming and interfere with daily life. The disorder typically begins in adolescence or early adulthood, but it can also start in childhood. Symptoms can vary in severity and may fluctuate over time, sometimes worsening during periods of stress.