Project details

Summary

What is the study about? What are you trying to find out?

Obsessive Compulsive Disorder (OCD) is a pattern of unreasonable thoughts and fears (obsessions) that can lead to repetitive behaviours (compulsions). These obsessions and compulsions can interfere with daily activities. Up to 60% of patients with OCD do not have an adequate response to approved oral treatments.

The purpose of this clinical research study is:

• evaluate the difference in how troriluzole works compared to placebo on your obsessive compulsive disorder (OCD) symptoms;
• evaluate how safe and well tolerated troriluzole is when administered as a single dose of 280 mg; and
• evaluate how troriluzole works compared to placebo using scales that assess other aspects of your health that may be affected by OCD.

Troriluzole is an investigational drug, which means that it has not been placed on the market yet and it is not yet approved by any Health Authority worldwide for the treatment of OCD or other diseases.

What does taking part involve?

This study is no longer looking for new participants but is still ongoing.

Study participation will last for up to 18 weeks and will include approximately 7 study visits to the study centre.

The study will consist of the following phases:

• Screening Phase (up to 42 days) – 1 visit;
• Randomization Phase (10 weeks) – 5 visits (Baseline, Weeks 2, 4, 8, 10);
• Follow-up (2 weeks) – 1 visit.

The total study treatment period will be ten (10) weeks, after which participants will return to the clinic two (2) weeks after discontinuing the study drug for a follow up safety visit or if eligible, will take part in the Open Label Extension Study. 

If you choose to participate and are suitable to do so, you will receive the investigational drug called troriluzole, for 48 weeks. Your participation in this study will last approximately 50 weeks and will include approximately 8 study visits to the study centre.

The study will consist of the following phases:

• Baseline Visit (day 1) – 1 visit
• Treatment Phase (48 weeks) – 7 visits (Weeks 2, 4, 8, 12, 24, 36, and 48)
• Follow-up (2 weeks) – 1 visit

Who is it for?

This study is no longer looking for new participants but is still ongoing.

We are looking for participants who have: 

• been diagnosed with Obsessive Compuslive Disorder (OCD);
• have not had an adequate response to approved oral treatments ( selective serotonin reuptake inhibitor excluding fluvoxamine or clomipramine treatment) 
• Be determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results and electrocardiogram testing. Subjects must be physically able and expected to complete the trial as designed

About 700 male and female participants (18-65 years old) with OCD will participate in this study. The study will last for approximately 18 weeks with up to 7 study visits to the study centre.

For the Open Label Extension Study, it is expected that approximately 1,200 participants globally will receive study drug in this study. In the United Kingdom (UK) about 49 participants are expected to participate in this study.

Why is it important? 

There may or may not be direct medical benefits to you from participating in this study. Your participation in this study will contribute to increasing information that may help treating patients with OCD and may contribute to improvements in medicine in general.

How can I find out more?

You can also visit the Biohaven OCD Clinical Trial project website here.

This study is no longer looking for new participants but is still ongoing.

However, if you have questions for the research team, click the button below to email us:

Email the research team