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

Biohaven Pharmaceuticals, Inc.140 个研究点分布在 1 个国家目标入组 456 人2020年12月22日

适应症Obsessive-Compulsive Disorder

干预措施Troriluzole Placebo

概览

阶段: 3 期
干预措施: Troriluzole
疾病 / 适应症: Obsessive-Compulsive Disorder
发起方: Biohaven Pharmaceuticals, Inc.
入组人数: 456
试验地点: 140
主要终点: The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS)
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 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)

注册库

clinicaltrials.gov

开始日期

2020年12月22日

结束日期

2025年10月27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 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
•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
•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

排除标准

•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 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
•Previous treatment in a study with troriluzole

研究组 & 干预措施

Troriluzole

Troriluzole - 2 100mg capsules once daily for the first two weeks. Troriluzole - 2 140mg capsules once daily from week two through week ten.

干预措施: Troriluzole

Placebo

Placebo - 2 100mg capsules once daily for the first two weeks. Placebo - 2 140mg capsules once daily from week two through week ten.

干预措施: Placebo

结局指标

主要结局

The total score on the Yale-Brown Obsessive Compulsive Scale (YBOCS)

时间窗: Change in total score from baseline, assessed at screening, baseline, week 4, 8 &10

Improvement is measured by a lower total score

次要结局

Frequency of SAEs and AEs leading to discontinuation(From Screening through study completion, up to 10 weeks)
Improvement in functional disability as assessed by the change in Sheehan Disability Scale (SDS)(From baseline through study completion (up to 10 weeks))
Improvement in global functioning responses assessed on the CGI-I scale.(From baseline through study completion (up to 10 weeks))