Xyrem and Brain Dopamine in Narcolepsy

• Status: Completed
• Trial end date: 2020-01-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centre for Addiction and Mental Health
• Treatments: Dopamine; Dopamine Agents; Sodium Oxybate

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