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Troriluzole for Obsessive-Compulsive Disorder
Phase 3
Recruiting
Research Sponsored by Biohaven Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
An inadequate response to current Standard of Care medication defined as selective serotonin reuptake inhibitor (excluding fluvoxamine) or clomipramine treatment at an adequate and stable dose for at least 8 weeks prior to screening and at least 12 weeks at baseline (adequate dose defined by USPI labeling); an inadequate response as defined per the MGH-TRQ-OCD, there has been minimal or no meaningful clinical benefit as perceived by the subject
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
Timeline
Screening 21 days
Treatment 12 weeks
Follow Up 2 weeks
Awards & highlights
Study Summary
This trial is testing if a new drug, troriluzole, is better than placebo at treating OCD when used with current OCD treatments.
Who is the study for?
This trial is for individuals with Obsessive-Compulsive Disorder (OCD) who haven't had enough improvement with standard treatments like certain antidepressants. They should have been on a stable dose for at least 12 weeks and be in good health overall, without serious psychiatric or medical conditions that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing troriluzole as an additional treatment to see if it's more effective than a placebo (a pill with no active drug). Participants will either receive troriluzole or the placebo alongside their current OCD medication.See study design
What are the potential side effects?
While specific side effects of troriluzole are not listed here, common side effects from similar medications may include nausea, headache, dizziness, and fatigue. The exact side effects will be monitored throughout the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with obsessive-compulsive disorder (OCD) for at least one year, as confirmed by a medical evaluation.
Timeline
Screening ~ 21 days1 visit
Treatment ~ 12 weeks6 visits
Follow Up ~ 2 weeks1 visit
Screening ~ 21 days
Treatment ~ 12 weeks
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Secondary outcome measures
Frequency of SAEs and AEs leading to discontinuation
Improvement in functional disability as assessed by the change in Sheehan Disability Scale (SDS)
Improvement in global functioning responses assessed on the CGI-I scale.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: TroriluzoleActive Control1 Intervention
Troriluzole - 2 100mg capsules once daily for the first two weeks. Troriluzole - 2 140mg capsules once daily from week two through week ten.
Group II: PlaceboPlacebo Group1 Intervention
Placebo - 2 100mg capsules once daily for the first two weeks. Placebo - 2 140mg capsules once daily from week two through week ten.
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Biohaven Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
36,435 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
2,326 Patients Enrolled for Obsessive-Compulsive Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have already been in a study that involved troriluzole treatment.You have been diagnosed with obsessive-compulsive disorder (OCD) for at least one year, as confirmed by a medical evaluation.You have been diagnosed with certain mental health disorders such as bipolar disorder, schizophrenia, or autism. You have also received certain treatments such as psychosurgery or ECT, or have medical conditions that may affect the safety and effectiveness of the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Troriluzole
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 21 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 2 Weeks after you stop receiving the treatment.
Obsessive-Compulsive Disorder Patient Testimony for trial: Trial Name: NCT04641143 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Federal Drug Administration cleared Troriluzole for public use?
"There is some evidence of efficacy and extensive safety data available from Phase 3 trials, so we have rated Troriluzole as a 3."
Answered by AI
If I'm younger than 70, can I still participate in this research?
"The age bracket for potential recruits begins at 18 years old and ends at 65."
Answered by AI
Have other research groups attempted anything similar to this project?
"Troriluzole is being studied in 6 active clinical trials across 8 countries and 161 cities. The first trial for Troriluzole was completed in 2016 by Biohaven Pharmaceuticals, Inc. That particular study involved 141 patients and completed Phase 2 & 3 of drug approval. Since then, 18279 more trials have been conducted."
Answered by AI
Are there any other research studies that have used Troriluzole?
"The first clinical trial for troriluzole was completed in 2016 at the University of Rochester Medical Center. Currently, there have been a total of 18279 studies. There are 6 trials that are still recruiting patients, with several locations in Dayton, Ohio."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
Florida
Other
Texas
How old are they?
18 - 65
What site did they apply to?
Altea Research
Baylor College of Medicine
Relaro Medical Trials
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
1
0
Why did patients apply to this trial?
Seeking professional results. treatment thatmay help money for trial. I found your information on Google Search.
PatientReceived no prior treatments
I have never had any drugs it's a mental fight every day. I have tried other medications, however I am willing to try something new.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How soon can I get in? what is the pay schedule? Have u seen positive outcomes?
PatientReceived 2+ prior treatments
What paperwork is required, is there payment?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- WR-PRI, LLC (Encino): < 24 hours
Average response time
- < 1 Day
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