A Single-Center, Double-Blind, Placebo-Controlled, Study to Evaluate Lumateperone, Flexible Doses of 21mg or 42mg in Patients With Moderate to Severe Childhood Onset Fluency Disorder, Stuttering.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Comprehensive Brief Stuttering Assessment-SR (CBSA-SR) previously know as Maguire-Leal-Garibaldi Self rated Stuttering Scale (MLGSSS)
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy and tolerability of Lumateperone in reducing stuttering symptoms.
The following scales and samples will be collected for clinical and functional outcomes. • MLGSSS • SSS • Stuttering Severity Instrument (SSI-IV) • PHQ-9 • Barnes Akathisia • SAS • AIMS • CGI-I • CGI-S
详细描述
This is a double-blind, placebo-controlled trial of Lumateperone in adults who suffer from developmental stuttering. Subjects with moderate to severe stuttering as measure by MLGSS scale will be enrolled. We anticipate screening a total of 30 subjects in anticipation of enrolling 24 suitable subjects for the trial. The subjects will be adults between the ages of 18-65, who have the capacity to consent for themselves. After providing written informed consent, potential subjects will undergo a thorough clinical screening.
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
- •Subjects will be included in the study only if they meet all the following criteria:
- •Subject must satisfy DSM-V criteria for childhood onset fluency disorder (stuttering).
- •The nature of stuttering must be developmental in origin with the onset prior to 8 years of age.
- •Subject must have a score of moderate or higher on the MLGSSS.
- •Subject agrees to use an acceptable method of contraception for the duration of the study.
- •Subject must be able to speak English.
- •Subjects must be adults between the ages of 18 - 65.
排除标准
- •Subjects will be excluded from the study if they meet one or more of the following criteria:
- •Subject has an unstable neurologic, psychiatric, or medical condition in the judgement of the investigator.
- •Subject (female) is pregnant.
- •Subject has evidence of moderate or severe renal or hepatic impairment at Screening.
- •Subjects currently taking any moderate or strong CYP3A4 inhibitor medications.
- •Subject who meets the DSM-5 criteria for moderate to severe substance use disorder within twelve months prior to study inclusion.
- •Subject has a positive pregnancy test at screening or on Day 1 prior to the start of study drug.
- •Subject that is lactating at screening or Day 1, prior to the start of study drug and does not agree to cease giving breast milk to child(ren), donating breast milk and/or providing breast milk to anyone for consumption, from Day 1 until 14 days after the last dose of study medication.
- •Any history of neuroleptic malignant syndrome (NMS).
- •Subject with a glycosylate hemoglobin (A1c) of greater than 6.4 percent.
研究组 & 干预措施
Lumateperone 21mg up to 42mg
flexible dosing
干预措施: Lumateperone (ITI-007) (Drug)
结局指标
主要结局
Comprehensive Brief Stuttering Assessment-SR (CBSA-SR) previously know as Maguire-Leal-Garibaldi Self rated Stuttering Scale (MLGSSS)
时间窗: last seven days, previous week (Minimum score 0 to Maximum score 100)
A self rater CBSA-SR includes 10 items to evaluate the different aspects of stuttering during the prior week (last 7 days)
Clinical Global Impression - Severity (CGI-S)
时间窗: Based primarily on symptoms and functioning over the past 7 days
Global assessment of stuttering severity (minimum score "1 Normal/Not ill" maximum score "7 Among the most extremely ill patients"
次要结局
- Clinical Global Impression - Improvement (CGI-I)(Rating for patients illness the past 7 days and measuring if symptoms and functioning have improved or worsened relative to their initial baseline)