A Study to Evaluate the Efficacy and Safety of Adjunctive Troriluzole in Obsessive-Compulsive Disorder

Biohaven

Status and phase: Completed; Phase 3

Conditions: Obsessive-Compulsive Disorder

Treatments: Drug: Troriluzole; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04693351

BHV4157-303

2024-514585-39-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

The purpose of this study was to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in participants with Obsessive Compulsive Disorder (OCD).

Enrollment: 589 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Primary diagnosis of OCD as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the Mini International Neuropsychiatric Interview (MINI) at screening; the duration of the participants illness must be ≥ 1year
2. An inadequate response to current standard of care (SOC) 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 US Package Insert [USPI] labelling); an inadequate response to current SOC based on the Yale-Brown Obsessive Compulsive Scale (YBOCS) score.
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. Participants must be physically able and expected to complete the trail as designed.

Key Exclusion Criteria:

1. Participants 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 Massachusetts General Hospital Treatment Response Questionnaire for OCD (MGH-TRQ-OCD).
2. Current or prior history of bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autism 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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589 participants in 2 patient groups, including a placebo group

Troriluzole

Experimental group

Description:

Participants received troriluzole 200 milligrams (mg) (100 mg\*2) capsules orally once daily for the first two weeks and up-titrated to 280 mg (140 mg\*2) capsules orally once daily for the next eight weeks, in the double-blind randomization phase.

Treatment:

Drug: Troriluzole

Placebo

Placebo Comparator group

Description:

Participants received placebo-matched to troriluzole capsules orally once daily for 10 weeks of the double-blind randomization phase.

Treatment:

Drug: Placebo