Efficacy and Safety Study of Adjunctive Troriluzule in Obsessive Compulsive Disorder

Study Overview
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Brief Summary
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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)

Official Title
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A Randomized, Double-Blind, Placebo- Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Drug: Troriluzole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 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 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. 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: 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. 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. Previous treatment in a study with troriluzole

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Troriluzole<br>Troriluzole- 2 100mg capsules once daily for the first two weeks. Troriluzole- 2 140mg capsules once daily from week two through week ten. | Drug: Troriluzole<br>* Two 100mg capsules daily for first two weeks and then two 140mg capsules daily from week 2 through week ten.<br>|
| Placebo Comparator: Placebo<br>Placebo- 2 100mg capsules once daily for the first two weeks. Placebo- 2 140mg capsules once daily from week two through week ten. | Drug: Placebo<br>* Two 100mg capsules daily for first two weeks and then two 140mg capsules daily from week 2 through week ten.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obsessive-Compulsive Disorder (OCD)