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Adjunctive Troriluzole for OCD

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
Are you b/t the ages of 18-65 years old?
Are you currently on a medication for your mental health?
Must not have
Current or prior history of: bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autism spectrum disorders, borderline personality disorder, antisocial personality disorder, Tourette's disorder, body dysmorphic disorder, hoarding disorder, or psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT); or general medical condition that may confound safety and/or efficacy results.
Timeline
Screening 1 day
Treatment Varies
Follow Up 3 days
Awards & highlights

Study Summary

This trial is testing if troriluzole could help people with OCD when used with other treatments.

Who is the study for?
This trial is for adults with Obsessive Compulsive Disorder (OCD) who haven't had enough improvement with standard treatments like certain antidepressants. They should be medically stable and able to complete the study, without a history of severe mental health disorders or brain injuries.Check my eligibility
What is being tested?
The trial is testing Troriluzole as an added treatment against a placebo in people with OCD. The goal is to see if it's effective and safe when used alongside current medications that aren't working well enough.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will be monitored for any adverse reactions to Troriluzole compared to those taking the placebo.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
You have a history of certain mental health disorders or treatments that may impact the study's safety and effectiveness.

Timeline

Screening ~ 1 day
Treatment ~ Varies
Follow Up ~3 days
This trial's timeline: 1 day for screening, Varies for treatment, and 3 days for reporting.

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 Disorder (YBOCS)
Secondary outcome measures
Frequency of SAEs and AEs leading discontinuation
Improvement in function disability as assessed by the change in the Sheehan Disability Scale (SDS)
Improvement in global functioning responses as assessed on the CGI-I scale.

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
Placebo - Randomization Phase/Troriluzole - Extension Phase
Troriluzole - Randomization Phase
Placebo - Randomization Phase
Troriluzole - Randomization Phase/Troriluzole - Extension Phase

Trial Design

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

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

Troriluzole 2023 Treatment Timeline for Medical Study. Trial Name: NCT04693351 — Phase 3
Obsessive-Compulsive Disorder Patient Testimony for trial: Trial Name: NCT04693351 — Phase 3

Frequently Asked Questions

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

When will Troriluzole be available for public consumption?

"Troriluzole has received a 3 on our Power team's safety scale. This is because it is a Phase 3 trial, meaning that there is both efficacy data as well as multiple rounds of safety data supporting its use."

Answered by AI

Are seniors a patient population being recruited for this research?

"The age limit for this study is 65 years old. All participants must be of legal age in their jurisdiction."

Answered by AI

What other scientific studies have included Troriluzole as a treatment?

"There are a total of 6 ongoing clinical trials researching Troriluzole. Out of these, 5 are in Phase 3. While the majority of the trials for Troriluzole are based in Savannah, Georgia, there are a total of 424 locations running clinical trials for this medication."

Answered by AI

Does this experiment currently have any participants?

"That is correct. As of today, this clinical trial is recruiting patients. The initial posting was on 29 January 2021 with the latest update on 4 October 2022. They are looking for 700 participants from 69 sites."

Answered by AI

How many people are able to enroll in this clinical trial?

"That is correct. As of October 4th, 2022, this clinical trial was last updated and is still actively recruiting patients. It was first posted on January 29th, 2021 and is looking for a total of 700 participants at 69 different sites."

Answered by AI

For which patients is this trial meant?

"The current study aims to enroll 700 participants that suffer from obsessive-compulsive disorder and are between 18-65 years old."

Answered by AI

Is this a new procedure that's being tested?

"Research for Troriluzole began in 2016 with the first study being sponsored by Biohaven Pharmaceuticals, Inc. After the initial trial with 141 participants, the drug received Phase 2 & 3 approval. Currently, there are 6 ongoing trials in 161 cities across 8 countries."

Answered by AI

In how many different medical facilities is this clinical trial taking place?

"As of now, the trial is running at 69 sites. To name a few, these locations are in Plano, DeSoto, and Hamilton. If you enroll, try and select a site that is close to you to cut down on travel time."

Answered by AI

Who else is applying?

What state do they live in?
California
Florida
Other
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Clinical Trial Network
AIM Trials
FutureSearch Trials of Dallas, LP
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0

Why did patients apply to this trial?

No have not tried meds. To see if this helps me. I am looking to make extra cash.
PatientReceived 1 prior treatment
Received email and helping people deal with OCD. With hopes of helping others and myself who struggle with this daily.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How many in-person visits are there? How long does the trial last? Is it paid?
PatientReceived 2+ prior treatments
What can I expect from the Trial? And when do I do the pre-trial questions?
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. Inquest Clinical Research: < 24 hours
  2. Richard H. Weisler, MD PA & Associates: < 48 hours
  3. FutureSearch Trials of Dallas, LP: < 48 hours
Typically responds via
Email
Phone Call
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety Study of Adjunctive Troriluzule in Obsessive Compulsive Disorder
2021. "Efficacy and Safety Study of Adjunctive Troriluzule in Obsessive Compulsive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04693351.
All > Ocd
~168 spots leftby Apr 2025
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