Efficacy and Safety Study of Adjunctive Troriluzole in Obsessive Compulsive Disorder

Launched by BIOHAVEN PHARMACEUTICALS, INC. · Nov 20, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating a medication called troriluzole to see if it can help people with Obsessive-Compulsive Disorder (OCD) who haven't had enough improvement with their current treatment. The study aims to determine how effective and safe troriluzole is when added to standard treatments for OCD compared to a placebo, which is a dummy pill that contains no active medication. The trial is currently looking for participants aged 18 to 65 who have been diagnosed with OCD for at least a year and have not responded well to their current medication.

Eligible participants will undergo evaluations to ensure they are medically stable and can safely take part in the trial. Those who join can expect to be monitored closely during the study, which will include regular visits and assessments. It's important to know that participants cannot have a history of certain serious mental health conditions or previous treatments with troriluzole. This trial offers an opportunity for individuals struggling with OCD to explore a new potential treatment option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Primary diagnosis of obsessive-compulsive disorder (OCD) as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the MINI at Screening; The duration of the subject's illness must be ≥ 1 year
• • 2. An inadequate response to current Standard of Care medication defined as selective serotonin reuptake inhibitor (excluding fluvoxamine) or clomipramine treatment at an adequate and stable dose for at least 8 weeks prior to screening and at least 12 weeks at baseline (adequate dose defined by USPI labeling); an inadequate response as defined per the MGH-TRQ-OCD, there has been minimal or no meaningful clinical benefit as perceived by the subject
• • 3. Determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Subjects must be physically able and expected to complete the trial as designed
• Exclusion Criteria:
• • 1. Subjects with a history of more than two (2) previous failed or inadequate treatment classes given for an adequate duration at an adequate dose as defined by the MGH-TRQ-OCD.
• • 2. Current or prior history of: bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, antisocial personality disorder, Tourette's disorder, body dysmorphic disorder, hoarding disorder; or psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT); or general medical condition that may confound safety and/or efficacy results
• • 3. Previous treatment in a study with troriluzole