Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder
- Registration Number
- NCT04708834
- Lead Sponsor
- Biohaven Pharmaceuticals, Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 1200
- 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
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Troriluzole (BHV-4157) Troriluzole (BHV-4157) 200 mg daily first 2 weeks, 280 daily following first 2 weeks
- Primary Outcome Measures
Name Time Method To evaluate the long term safety and tolerability of troriluzole as adjunctive therapy in subjects with OCD who have had an inadequate response to SSRI, clomipramine, venlafaxine or desvenfaxine treatment Change from Baseline to week 240 Percent change in treatment emergent adverse events, and clinical significant abnormalities in ECG's and lab values after Baseline.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (175)
Metropolitan Neuro Behavioral Institute
🇺🇸Chandler, Arizona, United States
Alea Research
🇺🇸Phoenix, Arizona, United States
NoeisisPharma, LLC
🇺🇸Phoenix, Arizona, United States
Atria Clinical Research
🇺🇸Little Rock, Arkansas, United States
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
CITrials (Clinical Innovations)
🇺🇸Bellflower, California, United States
Southern California Research, LLC
🇺🇸Beverly Hills, California, United States
Axiom Research, LLC
🇺🇸Colton, California, United States
Global Clinical Trials
🇺🇸Costa Mesa, California, United States
ProScience Research Group
🇺🇸Culver City, California, United States
Scroll for more (165 remaining)Metropolitan Neuro Behavioral Institute🇺🇸Chandler, Arizona, United States