Ibogaine to Determine Maximum Tolerated Dose (MTD) or Treat-to-Target Dose (TTD) for the Evaluation of Efficacy and Safety
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Stage 2 - Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) average score from Day 2 to Day 6
研究概览
简要总结
Study DMX-IB 201 is a Phase 1/2a study of ibogaine consisting of an initial single ascending dose escalation stage to determine the maximum tolerated dose (MTD) or treat-to-target dose (TTD) in healthy volunteers, followed by a randomized, double-blind, placebo-controlled proof of concept stage to demonstrate the efficacy, safety and tolerability of the selected dose in opioid-dependent patients who seek medically supervised opioid withdrawal
详细描述
Detailed description restricted as elements of this trial are part of a Phase 1 clinical trial.
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
- Double (Participant, Investigator)
盲法说明
Stage 1 (phase 1) of the study is single-blind (participant blinded); patients receive one initial dose of placebo, followed by one dose of IMP on the next day, and thereby serve as their own controls.
Stage 2 (phase 2a) is double-blinded. Patients will be randomized to receive either the IMP or placebo as a single dose
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single dose IMP (DMX-1002)
Stage 1 (single blind, placebo controlled): initial dose of placebo, followed by treatment at one of 4 ascending dose levels of IMP (3, 6, 9 or 12 mg/kg)
Stage 2 (blinded): MTD/TTD established in Stage 1 vs placebo (proof of concept)
干预措施: DMX-1002 (Drug)
Single dose IMP (DMX-1002)
Stage 1 (single blind, placebo controlled): initial dose of placebo, followed by treatment at one of 4 ascending dose levels of IMP (3, 6, 9 or 12 mg/kg)
Stage 2 (blinded): MTD/TTD established in Stage 1 vs placebo (proof of concept)
干预措施: Placebo (Drug)
Matching Placebo
Placebo using capsules identical to the IMP (DMX-1002)
干预措施: Placebo (Drug)
结局指标
主要结局
Stage 2 - Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) average score from Day 2 to Day 6
时间窗: Day 2 to Day 6
The SOWS-Gossop is a 10-item questionnaire to evaluate opioid withdrawal symptom severity. Each item is scored on a 4-point scale. Higher scores indicate greater severity (total score range 0-40).
次要结局
- Stage 2 - Proportion of subjects requiring clonidine for relief of withdrawal symptoms up to Day 6(Day 1 to Day 6)
- Stage 2 - Clinician-rated daily Clinical Global Impression - Improvement (CGI-I) score from Day 2 to Day 6(Day 2 to Day 6)
- Stage 2 - Daily subject-rated Visual Analog Scale for Efficacy (VAS-E) score from Day 2 to Day 6 and at Day 30(Day 2 to Day 6 and at Day 30)
- Stage 2 - Hamilton Depression Rating Scale (HAM-D) score at Day 6 and Day 30(Day 6 and Day 30)
- Stage 2 - Subject completion status at Day 6 (key secondary endpoint)(Day 6)
- Stage 2 - Objective Opiate Withdrawal Scale of Handelsman (OOWS Handelsman) average score from Day 2 to Day 6(Day 2 to Day 6)
- Stage 2 - Subject completion status at Day 30(Day 30)
- Stage 2 - Time to drop-out through Day 30(Day 1 to Day 30)