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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

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 18 days

Treatment 10 weeks

Follow Up2 weeks

Awards & highlights

Pivotal Trial

Study Summary

This trial is testing if a new drug, troriluzole, is better than placebo at treating OCD when used with current OCD treatments.

Eligible Conditions

Obsessive-Compulsive Disorder

Timeline

Screening ~ 18 days1 visit

Treatment ~ 10 weeks6 visits

Follow Up ~ 2 weeks1 visit

Screening ~ 18 days

Treatment ~ 10 weeks

Follow Up ~2 weeks

This trial's timeline: 18 days for screening, 10 weeks for treatment, and 2 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

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.

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

Do I qualify?Apply below to find out

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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

32,620 Total Patients Enrolled

3 Trials studying Obsessive-Compulsive Disorder

2,326 Patients Enrolled for Obsessive-Compulsive Disorder

Media Library

Troriluzole Clinical Trial Eligibility Overview. Trial Name: NCT04641143 — Phase 3

Obsessive-Compulsive Disorder Research Study Groups: Troriluzole, Placebo

Obsessive-Compulsive Disorder Clinical Trial 2023: Troriluzole Highlights & Side Effects. Trial Name: NCT04641143 — Phase 3

Troriluzole 2023 Treatment Timeline for Medical Study. Trial Name: NCT04641143 — Phase 3

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