NCT02637076

Xyrem and Brain Dopamine in Narcolepsy

Does Xyrem Influence Brain Dopamine in Patients With Narcolepsy? A PET Imaging Investigation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Centre for Addiction and Mental Health · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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.

Conditions

• Narcolepsy With Cataplexy
• Healthy Controls

Interventions

Type	Name	Description
DRUG	Xyrem	single 3.0 gram dose

Timeline

• Start date: 2016-01-01
• Primary completion: 2020-01-23
• Completion: 2020-01-23
• First posted: 2015-12-22
• Last updated: 2021-03-23
• Results posted: 2021-03-23

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study