Efficacy and Safety Study of Adjunctive Troriluzule in Obsessive Compulsive Disorder
Sponsored by Biohaven Pharmaceuticals, Inc.
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended a year ago
What is this trial about?
What are the Participation Requirements?
Key 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