Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Multicenter, Long-Term Open-Label Safety Study of Adjunctive Troriluzole in Subjects with Obsessive Compulsive Disorder

This study is testing a new medicine called Troriluzole for people who have been diagnosed with Obsessive Compulsive Disorder (OCD). It's an 'open-label' study, which means everyone involved knows they are receiving Troriluzole. The main goal is to carefully check the long-term safety of Troriluzole when it's used alongside a person's current OCD treatment. Researchers will be looking to see if there are any side effects or problems with the medicine over time. They will also check if people tolerate the medicine well and if it causes any changes in blood tests that might be important. This is a Phase 3 study, which means it’s one of the final steps before a new medicine might become available.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Biohaven Pharmaceuticals Inc.

Enrolment target

Start

01 Jul 2024

Obsessive Compulsive Disorder

What is this study about?

This research study is focused on a medicine called Troriluzole for adults who have Obsessive Compulsive Disorder (OCD). OCD is a condition where people experience unwanted thoughts or fears (obsessions) and often feel the need to repeat certain actions (compulsions) to try and ease their anxiety. The study aims to understand the long-term safety of Troriluzole when it's added to a person's existing treatments for OCD.

The study is designed to be 'open-label', meaning that both the patients and the doctors know that Troriluzole is the medicine being given. This approach helps researchers gather important information about how the medicine behaves in the body over an extended period and whether it's well-tolerated by patients when used in real-world conditions.

This is called a Phase 3 study, which is a key stage in developing new medicines. At this point, researchers are usually confident that the medicine shows promise, and they are now focusing on gathering extensive information about its safety and effectiveness in a larger group of people before it can be considered for wider use.

Key takeaways

This study is testing a new medicine, Troriluzole, for Obsessive Compulsive Disorder (OCD).
Its main goal is to check the long-term safety of Troriluzole when added to existing treatments.
It's an 'open-label' study, meaning everyone knows they are getting the medicine.
The study is for adults aged 18 and over, both men and women.
You'll have regular check-ups and follow-ups to monitor your health.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. There is no upper age limit, so older adults can also take part.

Both men and women are welcome to participate in this study. The study wants to check the medicine's safety across different people.

Crucially, you must have been diagnosed with Obsessive Compulsive Disorder (OCD). The study aims to help people with this specific condition.

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 (OCD)?
Are you currently receiving treatment for your OCD?
Are you comfortable potentially taking a new medicine for a long period?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to a clinic over a long period. During these visits, you would receive the study medication, Troriluzole, which you would take as prescribed. You would have various assessments, including blood tests, physical examinations, and questions about how you are feeling and any side effects you might experience. These assessments help the doctors monitor your health and how the medicine is affecting you. The total duration of your participation in the study has not been specified, but as it's a 'long-term' study, you should expect it to last for a significant period, potentially many months or even longer, with ongoing follow-up to check your health.

Potential risks and benefits

Participating in this study might offer the potential benefit of trying a new medicine for your OCD that could help manage your symptoms, although this study is primarily focused on safety. However, like all medicines, Troriluzole could have side effects, and some might be serious. The researchers will be closely monitoring your health to identify any issues. 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
Italy
—
Unverified
Spain

Common questions

What is Troriluzole?

Troriluzole is a new medicine being studied for Obsessive Compulsive Disorder (OCD). This trial is checking its long-term safety.

What does 'open-label' mean?

It means everyone involved – you and the study doctors – knows you are receiving the active medicine, Troriluzole.

Why is this study important?

It helps researchers understand how safe Troriluzole is over a longer time when used with existing OCD treatments.

Will I still take my other OCD medicines?

Yes, Troriluzole is being studied as an 'adjunctive' treatment, meaning it’s added to your current OCD medicines.

What is 'Phase 3'?

Phase 3 is an advanced stage of testing for a new medicine, gathering a lot of safety and effectiveness information before it can be made widely available.