A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Exploratory Study to Evaluate the Efficacy and Safety of Ecopipam Tablets in Adults With Childhood Onset Fluency Disorder (Stuttering)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 6
- 主要终点
- Change in Stuttering Severity Instrument, 4th edition (SSI-4) baseline to Week 12
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 exploratory study in adult subjects with childhood onset fluency disorder.
详细描述
At the Baseline visit, eligible subjects will be randomized 1:1 to receive either a target steady-state dose of ecopipam HCl ~2 mg/kg/day or matching placebo for a 12-week Treatment Period consisting of a 4-week Titration Phase followed by an 8-week Maintenance Phase.
Subjects will return to the clinic at 4, 8, and 12 weeks after Randomization and Follow-up visits 7 and 14 days after completing the Treatment Period or Early Discontinuation. Efficacy assessments will be conducted at Weeks 4, 8, and 12 and safety assessments will be conducted at all visits. Subjects will have adverse events and other safety parameters assessed by phone or video conference at Weeks 2, 6 and 10 and 30 days after the last study drug administration. Signs or symptoms of withdrawal, abuse, and dependence will be monitored throughout the study.
At the end of the Treatment Period or Early Discontinuation, subjects will taper study drug by 25 mg/day until off study drug, for up to 1 week.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to read and write in English and provide informed consent
- •18 years or older of age at screening
- •Weighs >= 45 kg (~99 lbs)
- •Satisfies DSM-5 criteria for childhood onset fluency disorder
- •History of stuttering for >=2 years with onset consistent to developmental in nature
- •Must meet an allowed severity of stuttering at screening and baseline, scored by a central rater
- •Completed an adequate course of speech therapy
- •Has a qualifying IOS or Android smartphone
- •Must discontinue all medications used to treat stuttering for at least 14 days prior to screening
- •Sexually active females of child bearing potential must be using effective contraception during and 30 days after participation
- •Sexually active males must use a double barrier method of contraception during and 30 days after participation
排除标准
- •Stuttering is related to a known neurological cause
- •Initiation of new behavioral therapies for stuttering within 10 weeks prior to baseline
- •Unstable medical illness or clinically significant abnormalities on screening tests/exams
- •At a significant risk of committing suicide
- •Are pregnant or lactating
- •Positive urine drug screen
- •Lifetime history of major depressive episode
- •History of seizures
- •Have been previously treated with ecopipam
- •Unstable use of medications prior to screening
- •Use of prohibited medications or need for medications which would have unfavorable interactions with ecopipam
- •Not suitable for study in the opinion of the Principle Investigator
研究组 & 干预措施
Ecopipam HCl ~2mg/kg/day
Ecopipam HCl tablets of 12.5, 50, and 75 mg for daily, oral administration for 12 weeks
干预措施: Ecopipam (Drug)
Matching Placebo
Matching placebo tablets for daily, oral administration for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Stuttering Severity Instrument, 4th edition (SSI-4) baseline to Week 12
时间窗: 12 weeks
Measures stuttering severity in children and adults
次要结局
- Clinical Global Impression - Severity (CGI-S) baseline to Week 12(12 weeks)