Long-term Safety Study of Adjunctive Troriluzole in Subjects with OCD
Research type
Research Study
Full title
A Multicenter, Long-Term Open-Label Safety Study of Adjunctive Troriluzole in Subjects with Obsessive Compulsive Disorder
IRAS ID
299151
Contact name
Damien Longson
Contact email
Sponsor organisation
Biohaven Pharmaceuticals, Inc
Eudract number
2020-004654-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 31 days
Research summary
OCD is pattern of unreasonable thoughts and fears(obsessions) that leads to repetitive behaviors(compulsions).OCD patients suffer from intrusive, obsessional thoughts that are typically ego-dystonic and commonly engage in time-consuming compulsive behaviors to attenuate their anxiety that can persist chronically over time. Existing therapies can significantly reduce symptoms in many patients. However, up to 60% of patients have an inadequate response to conventional pharmacotherapy. Troriluzole (BHV-4157) is glutamate modulating drug developed for the potential treatment of OCD as adjunctive therapy to standard of care treatments in subjects who have experienced an inadequate response to current pharmacotherapy. It is novel, rationally designed 3rd generation tripeptide prodrug of riluzole that potentially offers improved bioavailability, pharmacology, safety, and dosing. The primary objective of the study is 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 desvenlafaxine treatment. BHV4157-209 is a Phase 3, multicenter, 48-week open-label safety study designed to assess safety and tolerability of troriluzole as adjunctive therapy in subjects with OCD.Visits may include physical examinations, blood tests, urine samples, body scans, and questionnaires. The study will be conducted in Europe and North America, and will include approximately 1200 subjects, aged 18 to 65 (inclusive). Eligible participants must have a diagnosis of OCD, be 18 years of age or older, and meet other specific study criteria.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
21/EM/0167
Date of REC Opinion
10 Sep 2021
REC opinion
Further Information Favourable Opinion