NCT04693351已完成3 期
A Randomized, Double-Blind, Placebo- Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 589
- 试验地点
- 166
- 主要终点
- The total score on the Yale-Brown Obsessive Compulsive Disorder (YBOCS)
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in participants with Obsessive Compulsive Disorder (OCD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of OCD as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition as confirmed by the Mini International Neuropsychiatric Interview (MINI) at screening; the duration of the participants illness must be ≥ 1year
- •An inadequate response to current standard of care (SOC) 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 US Package Insert [USPI] labelling); an inadequate response to current SOC based on the Yale-Brown Obsessive Compulsive Scale (YBOCS) score.
- •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 trail as designed.
排除标准
- •Participants 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 Massachusetts General Hospital Treatment Response Questionnaire for OCD (MGH-TRQ-OCD).
- •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.
- •Previous treatment in a study with troriluzole.
研究组 & 干预措施
Troriluzole
Experimental
Participants received troriluzole 200 milligrams (mg) (100 mg*2) capsules orally once daily for the first two weeks and up-titrated to 280 mg (140 mg*2) capsules orally once daily for the next eight weeks, in the double-blind randomization phase.
干预措施: Troriluzole (Drug)
Placebo
Placebo Comparator
Participants received placebo-matched to troriluzole capsules orally once daily for 10 weeks of the double-blind randomization phase.
干预措施: Placebo (Drug)
结局指标
主要结局
The total score on the Yale-Brown Obsessive Compulsive Disorder (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
- Improvement in global functioning responses as assessed on the CGI-I scale.(From baseline through study completion (up to 10 weeks))
- Frequency of SAEs and AEs leading discontinuation(From Screening through Study completion, up to 10 weeks)
- Improvement in function disability as assessed by the change in the Sheehan Disability Scale (SDS)(From baseline through study completion (up to 10 weeks))
研究者
研究点 (166)
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