drugset / Trial / NCT02637076

Xyrem and Brain Dopamine in Narcolepsy

NCT02637076

Phase 4 Completed 17 enrolled Centre for Addiction and Mental Health
Non-randomizedParallel-groupOpen-labelBasic science

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.

Timeline

Start
2016-01
Primary completion
2020-01-23
Completion
2020-01-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Sodium Oxybate Unknown 3 g