Phase 4 N=17 Basic Science

Xyrem and Brain Dopamine in Narcolepsy

Narcolepsy With Cataplexy · Healthy Controls

Bottom Line

View on ClinicalTrials.gov: NCT02637076 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: [C-11]Raclopride BPND at 1 Hour Post Xyrem — 2.94; 3.01; 3.80; 3.70 BPND (Binding Potential) — p=0.31

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Xyrem (Drug)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Centre for Addiction and Mental Health
Primary completion: Jan 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY [C-11]Raclopride BPND at 1 Hour Post Xyrem	2.94; 3.01; 3.80; 3.70; 3.87; 4.11	0.31
PRIMARY % Change in PET [C11]Raclopride Binding From Baseline After Single Dose of Xyrem	-10.13; -2.07; -7.50; 0.17; -11.56; 0.72	—
PRIMARY [C-11]Raclopride BPND at 7 Hours Post Xyrem	2.33; 2.76; 2.83; 3.62; 2.75; 4.06	—
PRIMARY % Change in PET [C11]Raclopride Binding From Baseline After Single Dose of Xyrem	-10.13; -2.07; -7.50; 0.17; -11.56; 0.72	—
SECONDARY [C-11]DTBZ BPND at 5 Hours Post Xyrem	1.71; 1.82; 2.56; 2.65; 2.65; 3.12	—
SECONDARY % Change in PET [C-11] Dihydrotetrabenazine (DTBZ) Binding From Baseline to Five Hours Post Xyrem	2.00; -1.98; 6.10; 2.04; 6.51; 2.47	0.748
SECONDARY Blood Gamma-hydroxybutyrate (GHB) Concentration (AUC)	187.03; 178.49	—
SECONDARY Blood Gamma-hydroxybutyrate (GHB) Cmax	107; 107.37	—
SECONDARY Duration of Drowsiness	220.20; 92.4	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02637076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.