Glendale,
California
91206
Purpose:
The study's purpose is to evaluate the efficacy and safety of troriluzole as adjunctive
therapy compared to placebo in subjects with Obsessive Compulsive Disorder (OCD)
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