Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder

Have you been diagnosed with Obsessive-Compulsive Disorder (OCD)? Researchers are currently running a study to find out if a new medicine called Troriluzole can help reduce OCD symptoms. In this study, some people will receive Troriluzole, while others will receive a placebo – which looks like the real medicine but contains no active ingredient. This helps researchers understand the true effect of the drug. The main goal is to see how much OCD symptoms improve for those taking Troriluzole compared to those taking the placebo. They will also look at how severe OCD is, and how it impacts daily life. This is a 'Phase III' study, which means it’s a large and important step to confirm if the medicine is safe and effective before it can be considered for wider use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Biohaven Pharmaceuticals Inc.

Enrolment target

100

Start

30 Jul 2024

Obsessive Compulsive Disorder

What is this study about?

This research study is looking at a new medicine called Troriluzole as a possible treatment for people living with Obsessive-Compulsive Disorder, often called OCD. OCD can make daily life very difficult, as it involves unwanted thoughts and repeated actions that can be hard to control. The aim of this study is to see if adding Troriluzole to a person's existing care can help reduce these challenging symptoms.

To make sure the results are as clear and reliable as possible, the study uses a 'double-blind' approach. This means that neither you nor your study doctor will know whether you are receiving Troriluzole or a placebo (a dummy pill with no active medicine). This helps prevent any expectations from influencing how people feel or how symptoms are reported. By comparing the two groups, researchers can tell if Troriluzole truly has a positive effect on OCD symptoms.

The study is in its 'Phase III' stage. This is a significant point in the development of a new medicine, where researchers need to confirm that it works well and is safe in a larger number of people. If the results are positive, it means the medicine could potentially become a new treatment option for OCD in the future.

Key takeaways

This study is testing a new medicine for OCD called Troriluzole.
It aims to see if Troriluzole can reduce OCD symptoms.
Some participants will receive Troriluzole, others a placebo (dummy pill).
It's a 'double-blind' study, meaning you won't know which you're getting.
You must be 18 or older to potentially participate.
Participation is voluntary and you can leave at any time.

Who may be eligible?

To take part in this study, you must be an adult aged 18 or older. The study is open to both men and women.

Beyond these basic requirements, there will be specific health criteria that the study team will need to check. For example, they may need to confirm your OCD diagnosis and understand any other health conditions you might have or medicines you are currently taking.

It's important to have a chat with the study team or your own doctor if you are interested, as they will go through all the detailed eligibility checks with you to see if this study is a good fit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with Obsessive-Compulsive Disorder?
Are you able to attend regular appointments at a study clinic?
Are you willing to potentially take either a new medicine or a dummy pill?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either the study medicine, Troriluzole, or a placebo, in capsule form, in a fixed dose. You would have regular visits to the study clinic where doctors and nurses would check on your health and how you're feeling. During these visits, you'll likely complete questionnaires designed to measure your OCD symptoms. These assessments would happen over a set period, from when you start the study up until a follow-up after you stop taking the study medicine. The full duration of your involvement, including all visits and follow-ups, would be explained to you by the research team.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. A potential benefit could be that Troriluzole helps improve your OCD symptoms, though there's no guarantee, as some participants will receive a placebo. There might also be unknown side effects from the study medicine. All known risks will be fully explained to you before you decide to join. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Spain
—
Unverified
Italy

Common questions

What is Obsessive-Compulsive Disorder (OCD)?

OCD is a mental health condition where a person has unwanted thoughts and urges (obsessions) and often repeats certain actions or behaviours (compulsions) because of them.

What is Troriluzole?

Troriluzole is an experimental medicine being tested in this study to see if it can help reduce OCD symptoms.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredient. It helps researchers fairly compare the effects of the actual drug.

What does 'double-blind' mean?

Double-blind means that neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This helps prevent bias in the results.

How long will the study last?

The research team will tell you the exact duration, including how long you would take the medicine and how many follow-up visits are needed.