A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200 in Treatment-Seeking Individuals With Methamphetamine Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 61
- 试验地点
- 7
- 主要终点
- Percent of 20 Weeks Abstinent From Stimulants Following a 4-week Grace Period
研究概览
简要总结
This Phase 2 study will evaluate the safety and efficacy of monthly intravenous doses of IXT-m200 in treatment-seeking individuals with methamphetamine (METH) use disorder. The hypothesis are that following an initial relapse, IXT-m200 will reduce the occurrence of stimulant-positive saliva samples compared to placebo and improve the signs and symptoms of METH Use Disorder (MUD).
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
- Triple (Participant, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
IXT-m200
Anti-methamphetamine monoclonal antibody, dose levels of 1.5 and 3 g
干预措施: IXT-m200 (Drug)
Placebo
Saline
干预措施: Placebo (Other)
结局指标
主要结局
Percent of 20 Weeks Abstinent From Stimulants Following a 4-week Grace Period
时间窗: 20 weeks
The difference in group means between the IXT-m200 and placebo groups for the percent of 20 weeks abstinent from stimulants following a 4-week grace period as measured by saliva screens in treatment-seeking individuals with Methamphetamine Use Disorder. All observations will be used, regardless of whether a participant discontinued treatment early. All missing values will be imputed assuming the participant is not abstinent.
次要结局
- Change From Screening in Participant-rated Quality of Life as Measured by the Treatment Effectiveness Assessment at Week 13, 25, and 33.(Weeks 13, 25, and 33)
- Proportion of Responders in Early Remission at Week 25 as Measured by DSM-5 Criteria(25 weeks)
- Difference Between Groups in Clinical Global Impression of Change (CGIC) at Week 13, 25, and 33(Weeks 13, 25, and 33)
- Difference Between Groups in Patient Global Impression of Change (PGIC) at Week 13, 25, and 33(Weeks 13, 25, and 33)