Does Xyrem Influence Brain Dopamine in Patients With Narcolepsy? A PET Imaging Investigation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- % Change in PET [C11]Raclopride Binding From Baseline After Single Dose of Xyrem
研究概览
简要总结
The overall aim of this investigation is to establish whether an action of Xyrem® on the brain dopamine system in patients with narcolepsy, and in a comparison control group, might explain part of the anti-narcoleptic effect of the drug.
Trial Objective is to establish, using positron emission tomography (PET), in Xyrem®-naïve narcolepsy with cataplexy patients, and in matched controls, whether a single dose of Xyrem® causes changes in striatal binding of 11C-raclopride and 11C-DTBZ that would suggest altered activity of brain dopamine neurones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •current diagnosis of narcolepsy with cataplexy OR healthy control
排除标准
- •use of any sedative hypnotics, tranquilizers, anticonvulsants, antihistamines (except non-sedating), benzodiazepines, clonidine or any medication known to affect dopamine at start of baseline period
- •significant unstable or uncontrolled medical/psychiatric disease
- •significant history of head trauma/surgery or seizure disorder
- •radiation exposure exceeding 20mSv in last 12 months
- •pregnancy
- •substance abuse/dependence (including alcohol)
- •have sleep apnea, or are shift workers
- •on a sodium-restricted diet
- •has ever taken Xyrem / sodium oxybate / GHB at any time
- •claustrophobia
- •metal implants / objects in the body that may interfere with MRI
- •succinic semialdehyde dehydrogenase deficiency
研究组 & 干预措施
narcolepsy with cataplexy
patients given single dose of Xyrem
干预措施: Xyrem (Drug)
healthy controls
healthy controls given a single dose of Xyrem
干预措施: Xyrem (Drug)
结局指标
主要结局
% Change in PET [C11]Raclopride Binding From Baseline After Single Dose of Xyrem
时间窗: 7 hours post Xyrem
\[C-11\] raclopride is a radioligand that binds to the D2/3 dopamine receptor in the dopamine-rich striatum and which is sensitive to dopamine occupancy. % change was calculated as follows: (7 hours BPND - baseline BPND)/baseline BPND \*100; Mean % change represents the mean of each participant's individual % change within the group.
[C-11]Raclopride BPND at 7 Hours Post Xyrem
时间窗: 7 hours post Xyrem
BPND (Binding Potential) of \[C-11\]raclopride measures 7 hours after taking a single 3g dose of Xyrem.
[C-11]Raclopride BPND at 1 Hour Post Xyrem
时间窗: 1 hour post Xyrem
BPND (Binding Potential) of \[C-11\]raclopride measures 1 hour after taking a single 3g dose of Xyrem.
次要结局
- Blood Gamma-hydroxybutyrate (GHB) Cmax(multiple time points from 0 to 7 hours post-Xyrem)
- Duration of Drowsiness(observed after receiving single dose of Xyrem, up to 9 hours)
- [C-11]DTBZ BPND at 5 Hours Post Xyrem(5 hours post single Xyrem dose)
- % Change in PET [C-11] Dihydrotetrabenazine (DTBZ) Binding From Baseline to Five Hours Post Xyrem(5 hours post single Xyrem dose)
- Blood Gamma-hydroxybutyrate (GHB) Concentration (AUC)(multiple time points from 0 to 7 hours post-Xyrem)
研究者
Stephen Kish
Senior Scientist, Head Human Brain Lab
Centre for Addiction and Mental Health