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Troriluzole for Obsessive-Compulsive Disorder

Phase 2 & 3
Waitlist Available
Research Sponsored by Biohaven Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently experiencing non-response or inadequate response to current standard of care (SOC) medication with a Yale-Brown Obsessive Compulsive Scale total score ≥ 19 at screening and Baseline
Minimum of 6 years of education or equivalent and sufficiently fluent in English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 96 weeks
Awards & highlights

Study Summary

This trial will compare the effectiveness of BHV-4157 to a placebo in people with OCD.

Who is the study for?
This trial is for adults with Obsessive Compulsive Disorder (OCD) who haven't had enough improvement from certain medications like SSRIs or clomipramine. Participants must be medically stable, able to perform tests and interviews, understand English well, and agree to use two forms of contraception if applicable. They should have moderate to severe OCD symptoms despite current treatment but no other major psychiatric conditions that could affect their OCD assessment.Check my eligibility
What is being tested?
The study is testing the effectiveness of troriluzole as an additional treatment compared to a placebo in people with OCD who don’t respond well enough to standard treatments. Troriluzole's benefits will be evaluated alongside participants' ongoing medication regimens.See study design
What are the potential side effects?
While specific side effects for troriluzole are not listed here, similar medications can cause nausea, headache, dizziness, fatigue, sleep disturbances and may interact with other drugs. Any new or unusual symptoms experienced during the trial should be reported.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My current medication for OCD isn't working well, and my symptoms are severe.
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I have at least 6 years of education and am fluent in English.
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My health is stable based on recent exams and tests.
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I agree to use two forms of birth control during the study.
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I have been diagnosed with OCD according to DSM-5.
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I can hear, see, and communicate well enough to undergo tests and interviews.
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I agree to use two forms of birth control during the study.
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I am currently taking an SSRI, clomipramine, venlafaxine, or desvenlafaxine.
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I have had OCD for at least a year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 96 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 96 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score
Secondary outcome measures
Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score
Change From Baseline in Functional Disability Assessed Using the Sheehan Disability Scale (SDS) Total Score
Change From Baseline in the Y-BOCS Obsessions Sub-Scale Score
+3 more
Other outcome measures
Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score at Weeks 4 and 8

Side effects data

From 2020 Phase 3 trial • 881 Patients • NCT03829241
9%
Nausea
5%
Fatigue
5%
Upper respiratory tract infection
4%
Headache
3%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Troriluzole - Randomization Phase
Placebo - Randomization Phase
Troriluzole - Randomization Phase/Troriluzole - Extension Phase
Placebo - Randomization Phase/Troriluzole - Extension Phase

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TroriluzoleExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Troriluzole
2019
Completed Phase 3
~890

Find a Location

Who is running the clinical trial?

Biohaven Pharmaceuticals, Inc.Lead Sponsor
47 Previous Clinical Trials
36,992 Total Patients Enrolled
3 Trials studying Obsessive-Compulsive Disorder
2,600 Patients Enrolled for Obsessive-Compulsive Disorder

Media Library

BHV-4157 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03299166 — Phase 2 & 3
Obsessive-Compulsive Disorder Research Study Groups: Troriluzole, Placebo
Obsessive-Compulsive Disorder Clinical Trial 2023: BHV-4157 Highlights & Side Effects. Trial Name: NCT03299166 — Phase 2 & 3
BHV-4157 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03299166 — Phase 2 & 3
Obsessive-Compulsive Disorder Patient Testimony for trial: Trial Name: NCT03299166 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical research only being conducted with individuals above a certain age?

"The age range for eligible participants in this trial are individuals who are 18 years old or older, but younger than 65."

Answered by AI

Are people still being accepted into the program?

"No, this particular trial is not accepting patients at the moment. Although it was last updated on October 4th, 2022, the study has not been actively recruiting since December 19th, 2017 according to clinicaltrials.gov. There are plenty of other opportunities for interested individuals though; 116 other trials are currently looking for participants."

Answered by AI

Do numerous facilities in the United States offer this kind of clinical trial to patients?

"This clinical trial is enrolling patients at 57 sites. The locations of these centres include major cities such as Charlotte, Boston and Dallas. There are also many other options available to limit travel if necessary."

Answered by AI

Could I possibly qualify to take part in this research?

"This study is looking for 248 patients with obsessive-compulsive disorder (OCD) between the ages of 18 and 65. To be eligible, subjects must: - Be able to understand and agree to comply with the prescribed dosage regimens and procedures; - Report for regularly scheduled office visits; - Reliably communicate with study personnel about adverse events and concomitant medications; - Have adequate hearing, vision, and language skills to perform neuropsychiatric testing and interviews as specified in the protocol; - Y-BOCS total score must be ≥ 19 at Screening and Baseline"

Answered by AI

Who else is applying?

What state do they live in?
Other
North Carolina
Florida
Oregon
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
3+
What site did they apply to?
FutureSearch Trials of Dallas, LP

Why did patients apply to this trial?

I need help no meds work. So I am on sertraline and Vanwall and hydroxyzine currently and smoke marijuana to help with my anxiety but I realize recently that when I was a kid like four or five are used to be, I was sent to school there allow me to learn how to catch a ball and see even words in general and then after third or fourth grade I no longer had an issue it was gone and I’m four years old and now it’s an issue and I have OCD so bad it’s not even Funny And so many other things I just want help that’s all.
PatientReceived no prior treatments
~59 spots leftby Mar 2025