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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 study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario De Salamanca Salamanca Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy

Other Sites

Site Name City Country Status
ASST Fatebenefratelli Sacco Milan Italy
Ospedale San Raffaele S.r.l. Milan Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Hospital Alvaro Cunqueiro Vigo Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
03.05.2021
Spain Spain
Not recruiting
03.05.2021

Trial locations

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.

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.

Trial ID:
2024-512108-20-00
NCT ID:
NCT04708834
Trial Phase:
Therapeutic confirmatory (Phase III)

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