An Exploratory Open-Label, Phase 1b, Ascending Dose Study to Evaluate the Effects of Oral 3-[2-(Dimethylamino)Ethyl]-1h-indol-4-yl Dihydrogen Phosphate (Psilocybin, BPL-PSILO) on Cognition in Patients With Chronic Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Percentage of patients with treatment emergent AEs (TEAES)
研究概览
简要总结
This exploratory open-label phase 1b, ascending dose study is to evaluate the effects of psilocybin on cognition in patients with Chronic Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA)
详细描述
The study aims to:
Determine the safety and tolerability of psilocybin when administered to patients with chronic SUNHA
Determine the effects of psilocybin on cognition when administered to patients with chronic SUNHA
Explore the change in frequency, duration, and intensity of headache attacks with escalating doses of psilocybin in patients with chronic SUNHA
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •* Diagnosed with chronic SUNHA
排除标准
- •* Other comorbidities
研究组 & 干预措施
Psilocybin
干预措施: Psilocybin (Drug)
结局指标
主要结局
Percentage of patients with treatment emergent AEs (TEAES)
时间窗: From first dose administered through to the last follow up visit, approximately 39 days
Treatment-related changes in Rapid Visual Information Processing (RVP) scores and evaluation of dose response
时间窗: From first dose administered until the las dose administered, approximately 11 days
Change in frequency of headache attacks
时间窗: From screening until the follow up visit, approximately 39 days
Treatment-related changes in Paired Associates Learning (PAL) scores and evaluation of dose response
时间窗: From first dose administered until the las dose administered, approximately 11 days
Treatment-related changes in Spatial Working Memory (SWM) scores and evaluation of dose response
时间窗: From first dose administered until the las dose administered, approximately 11 days
Treatment-related changes in Reaction Time Index (RTI) scores and evaluation of dose response
时间窗: From first dose administered until the las dose administered, approximately 11 days
Change in intensity of headache attacks
时间窗: From screening until the follow up visit, approximately 39 days
Patients will complete a diary on a daily basis and capture the intensity of their headaches by assigning a score out of 10 where 0 is pain free and 10 is excruciating pain
Change in duration of headache attacks
时间窗: From screening until the follow up visit, approximately 39 days
次要结局
未报告次要终点