Clinical Trial: Xyrem and Brain Dopamine in Narcolepsy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

The overall aim is to establish whether the drug Xyrem® has an action on the brain dopamine system in patients with narcolepsy.

Trial Objective is to establish, using positron emission tomography (PET), in Xyrem®-naïve narcolepsy with cataplexy patients, 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.

Detailed Summary:
Sponsor: Centre for Addiction and Mental Health

Current Primary Outcome: Change in PET 11C-raclopride binding from baseline to 7 hours post Xyrem [ Time Frame: 7 hours ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Blood gamma-hydroxybutyrate (GHB) concentration [ Time Frame: multiple time points from 0 to 7 hours post-Xyrem ]

Original Secondary Outcome: Same as current

Information By: Centre for Addiction and Mental Health

Dates:
Date Received: December 17, 2015
Date Started: January 2016
Date Completion: December 2018
Last Updated: July 8, 2016
Last Verified: July 2016