Efficacy and Safety Study of Adjunctive Troriluzule in Obsessive Compulsive Disorder

Phase 3

Active, not recruiting

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Drug: Placebo; Drug: Troriluzole

• Registration Number: NCT04693351
• Lead Sponsor: Biohaven Pharmaceuticals, Inc.

Brief Summary

The study's purpose its to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive Disorder (OCD)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-30
• Study First Submitted QC: 2020-12-30
• Study First Posted: 2021-01-05
• Study Start: 2021-01-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-11
• Last Update Posted: 2025-01-14
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 700

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 subjects illness must be ≥ 1year
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 too current standard of car base on the 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. Subjects must be physically able and expected to complete the trail as designed.

Key

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo- 2 100mg capsules once daily for the first two weeks. Placebo- 2 140mg capsules once daily from week two through week ten.
Troriluzole	Troriluzole	Troriluzole- 2 100mg capsules once daily for the first two weeks. Troriluzole- 2 140mg capsules once daily from week two through week ten.

Primary Outcome Measures

Name	Time	Method
The total score on the Yale-Brown Obsessive Compulsive Disorder (YBOCS)	Change in total score from baseline, assessed at screening, baseline, week 4, 8 &10	Improvement is measured by a lower total score

Secondary Outcome Measures

Name	Time	Method
Improvement in global functioning responses as assessed on the CGI-I scale.	From baseline through study completion (up to 10 weeks)	Change is measured as "much improved" or very much improved" on the CGI-I scale.
Frequency of SAEs and AEs leading discontinuation	From Screening through Study completion, up to 10 weeks	Percent difference between troriluzole vs placebo treatment emergent adverse events
Improvement in function disability as assessed by the change in the Sheehan Disability Scale (SDS)	From baseline through study completion (up to 10 weeks)	Change is measured as "mild" or "moderate" on the SDS

Trial Locations

Locations (88)

Alea Research; 🇺🇸 Phoenix, Arizona, United States

ProScience Research Group; 🇺🇸 Culver City, California, United States

Kaizen Brain Center; 🇺🇸 La Jolla, California, United States

Om Research LLC; 🇺🇸 Lancaster, California, United States

CalNeuro Research Group; 🇺🇸 Los Angeles, California, United States

Lumos Clinical Research Center, LLC; 🇺🇸 San Jose, California, United States

Velocity Clinical Research; 🇺🇸 Santa Ana, California, United States

California Neuroscience Research Medical Group, Inc.; 🇺🇸 Sherman Oaks, California, United States

Pacific Clinical Research Medical Group; 🇺🇸 Upland, California, United States

Mountain View Clinical Research; 🇺🇸 Denver, Colorado, United States

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