Long-term Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder

Overview

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).

Full Title of Study: “A Multicenter, Long-Term Open-Label Safety Study of Adjunctive Troriluzole in Subjects With Obsessive Compulsive Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2025

Interventions

  • Drug: Troriluzole (BHV-4157)
    • 200 mg daily first 2 weeks, 280 daily for following 46 weeks

Arms, Groups and Cohorts

  • Experimental: Troriluzole (BHV-4157)
    • 200 mg daily first 2 weeks, 280 daily for following 46 weeks

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: Change from Baseline to week 48
    • Percent change in treatment emergent adverse events, and clinical significant abnormalities in ECG’s and lab values after Baseline.

Participating in This Clinical Trial

Key Inclusion Criteria:

  • 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 Criteria:

  • 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;

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Biohaven Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

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