This research study is investigating troriluzole (BHV-4157) as a possible treatment for obsessive compulsive disorder (OCD) compared to placebo. Up to 60% of patients with OCD do not have adequate response to approved oral treatments. Troriluzole is an "investigational" or experimental drug, which means that the drug has not been approved by regulatory authorities for use outside of research studies.
Troriluzole is thought to work like its main by-product riluzole which has been FDA approved for ALS treatment and tends to block certain mechanisms in the body that cause obsessions and compulsions. The study drug also has better oral bioavailability, no food restrictions, lower overall burden to the liver, reduced pharmacokinetic variability, and only has to be dosed once daily compared to riluzole.
Approximately, 700 participants will receive the study drug or placebo. Participation in this study will last about 18 weeks which includes at least 7 office visits at the study center. Biohaven is also sponsoring a 48-week open-label extension available for those who complete the double-blind portion.
Sponsor: Biohaven Pharmaceuticals, Inc.
Indication: Obsessive Compulsive Disorder
Study Drug: Troriluzole (BHV-4157)
Study Phase: 3
Screening phase – up to 42 days – 1 visit, 1 SAFER call
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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