A Randomized, Double-blind, Placebo-controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder

Biohaven Pharmaceuticals, Inc.55 个研究点分布在 1 个国家目标入组 426 人2017年12月19日

适应症Obsessive-Compulsive Disorder

干预措施Troriluzole Placebo

概览

阶段: 2 期
干预措施: Troriluzole
疾病 / 适应症: Obsessive-Compulsive Disorder
发起方: Biohaven Pharmaceuticals, Inc.
入组人数: 426
试验地点: 55
主要终点: Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score
状态: 已完成
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The purpose of this study is to evaluate the efficacy of troriluzole as adjunctive therapy versus placebo in participants with obsessive compulsive disorder (OCD) who had an inadequate response to selective serotonin reuptake inhibitor (SSRI), clomipramine, venlafaxine, or desvenlafaxine treatment

注册库

clinicaltrials.gov

开始日期

2017年12月19日

结束日期

2025年12月8日

最后更新

3个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Biohaven Pharmaceuticals, Inc.

责任方

Sponsor

入排标准

入选标准

•Primary diagnosis of OCD as per the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5).
•Participants must be currently experiencing non-response or inadequate response to their current standard of care (SOC) medication defined as:
•Participant Yale-Brown Obsessive Compulsive Scale total score must be ≥ 19 at screening and Baseline, reflecting moderate or severe OCD symptoms.
•Participants must currently be on a SSRI, clomipramine, venlafaxine or desvenlafaxine.
•Determined by the investigator to be medically stable at baseline/randomization as assessed by medical history, physical examination, laboratory test results, and electrocardiogram testing. Participants must be physically able and expected to complete the trial as designed;
•Minimum of 6 years of education or equivalent and sufficiently fluent in English to complete necessary scales and understand consent forms;
•Participants must have adequate hearing, vision, and language skills to perform neuropsychiatric testing and interviews as specified in the protocol;
•Participants must be able to understand and agree to comply with the prescribed dosage regimens and procedures; report for regularly scheduled office visits; and reliably communicate with study personnel about adverse events and concomitant medications;
•It is required that all women of child-bearing potential (WOCBP) who are sexually active agree to use two methods of contraception for the duration of the study (i.e. beginning 30 days prior to baseline and extending to 30 days after the last dose of study drug).
•WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to dosing at Baseline;

排除标准

•Participants should be excluded with a history of more than 2 previous failed treatment trials of SSRIs, clomipramine, venlafaxine, or desvenlafaxine (not including the current SSRI trial) given for an adequate duration at an adequate dose as defined by the following criteria taken from the Massachusetts General Hospital Treatment Response Questionnaire for OCD (MGH-TRQ-OCD) as follows:
•Treatment failure / non-response: As per the MGH-TRQ-OCD, there has been minimal or no meaningful clinical benefit as perceived by the participant despite an adequate dose and duration of treatment;
•Adequate duration: At least 10 weeks of treatment with SSRI, clomipramine, venlafaxine, or desvenlafaxine
•Adequate dose: Defined by the the United States Prescribing Information labeling.
•Evidence at screening or baseline of any medical or psychiatric condition other than OCD that could predominantly explain or contribute significantly to the subjects' symptoms or that could confound assessment of OCD symptoms
•Mini Mental State Examination (MMSE) score of \< 24 at Screening
•Current or prior history, per DSM-5 criteria, of bipolar I or II disorder, schizophrenia or other psychotic disorders, schizoaffective disorder, autism or autistic spectrum disorders, borderline personality disorder, antisocial personality disorder, body dysmorphic disorder, hoarding disorder (symptoms of hoarding disorder as part of the OCD diagnosis are allowed, but a primary diagnosis of hoarding disorder is excluded); a current diagnosis of Tourette's disorder is also excluded;
•Any eating disorder within the last 12 months;
•Acute suicidality or suicide attempt or self-injurious behavior in the last 6 months;
•History of psychosurgery, Deep Brain Stimulation (DBS) or Electroconvulsive Therapy (ECT).

研究组 & 干预措施

Troriluzole

干预措施: Troriluzole

Placebo

干预措施: Placebo

结局指标

主要结局

Change From Baseline in the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score

时间窗: Baseline, Week 12

The Y-BOCS is a clinician-administered scale used extensively in research and clinical practice to both rate severity of obsessive compulsive disorder (OCD) and to monitor improvement during treatment. It is designed to rate the severity of obsessions and compulsions as well as the type of symptoms in patients with OCD. The scale consists of 10 items; the first 5 items assess obsessions, and the last 5 items assess compulsions. Subscale scores can be calculated for obsessions and compulsions, each on a scale of 0 to 20. A total score ranging from 0 to 40 can then be correlated to overall severity. The higher the number on the Y-BOCS, the more severe the symptoms.

次要结局

Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the DB Randomization Phase(Up to 12 weeks)
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation in the Open-Label Extension Phase(Up to 192 weeks)
Number of Participants With Clinically Significant Laboratory Abnormalities During the DB Randomization Phase(Up to 12 weeks)
Change From Baseline in Functional Disability Assessed Using the Sheehan Disability Scale (SDS) Total Score(Baseline, Week 12)
Change From Baseline in Clinical Global Impression of Severity Scale (CGI-S) Score(Baseline, Week 12)
Change From Baseline in the Y-BOCS Obsessions Sub-Scale Score(Baseline, Week 12)