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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

BHV4157-303

Status

Recruiting

Type

Interventional

Phase

Phase 3

Placebo

Yes

Accepting

18-75 Years
18 to 65 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial about?

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)

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

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