Clinical trial NCT02637076: Xyrem and Brain Dopamine in Narcolepsy
Official title: Does Xyrem Influence Brain Dopamine in Patients With Narcolepsy? A PET Imaging Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Narcolepsy With Cataplexy
Healthy Controls
Keywords: Xyrem
narcolepsy with cataplexy
positron emission tomography
dopamine
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 17
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be recruited to fill 2 separate study groups: 1) participants with a diagnosis of narcolepsy with cataplexy; 2) healthy controls.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* current diagnosis of narcolepsy with cataplexy OR healthy control

Exclusion Criteria:

* 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

Primary outcomes:
measure: [C-11]Raclopride BPND at 1 Hour Post Xyrem
timeFrame: 1 hour post Xyrem
measure: % Change in PET [C11]Raclopride Binding From Baseline After Single Dose of Xyrem
timeFrame: 1 hour post Xyrem
measure: [C-11]Raclopride BPND at 7 Hours Post Xyrem
timeFrame: 7 hours post Xyrem
measure: % Change in PET [C11]Raclopride Binding From Baseline After Single Dose of Xyrem
timeFrame: 7 hours post Xyrem
Secondary outcomes:
measure: [C-11]DTBZ BPND at 5 Hours Post Xyrem
timeFrame: 5 hours post single Xyrem dose
measure: % Change in PET [C-11] Dihydrotetrabenazine (DTBZ) Binding From Baseline to Five Hours Post Xyrem
timeFrame: 5 hours post single Xyrem dose
measure: Blood Gamma-hydroxybutyrate (GHB) Concentration (AUC)
timeFrame: multiple time points from 0 to 7 hours post-Xyrem
measure: Blood Gamma-hydroxybutyrate (GHB) Cmax
timeFrame: multiple time points from 0 to 7 hours post-Xyrem
measure: Duration of Drowsiness
timeFrame: observed after receiving single dose of Xyrem, up to 9 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health (CAMH)
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Stephen J Kish, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: