Status:
ENROLLING_BY_INVITATION
Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder
Lead Sponsor:
Biohaven Pharmaceuticals, Inc.
Conditions:
Obsessive Compulsive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with obsessive compulsive disorder (OCD).
Eligibility Criteria
Inclusion
- Key
- Eligible subjects are those subjects who complete study BHV4157-302 or BHV4157-303 and for whom the investigator believes open-label treatment offers an acceptable risk-benefit profile.
- Determined by the investigator to be medically stable at the week 10 visit of BHV4157-302 or BHV4157-303, as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing.
- It is required that all women of child-bearing potential (WOCBP) who are sexually active agree to use two methods of contraception for the duration of the study
- Key
Exclusion
- Subjects who did not successfully complete 10 weeks of treatment in the BHV4157-302 or BHV4157-303 study.
- Acute suicidality or suicide attempt or self injurious behavior in the last 12 months.
- Patients who may have received a non-biological investigational agent in any clinical trial within 30 days or a biological agent within 90 days prior to entry, other than what was received in BHV4157-302 or BHV4157-303;
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT04708834
Start Date
March 30 2021
End Date
June 1 2026
Last Update
January 17 2025
Active Locations (175)
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1
Metropolitan Neuro Behavioral Institute
Chandler, Arizona, United States, 85226
2
Alea Research
Phoenix, Arizona, United States, 85012
3
NoeisisPharma, LLC
Phoenix, Arizona, United States, 85016
4
Atria Clinical Research
Little Rock, Arkansas, United States, 72209