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Xyrem and Brain Dopamine in Narcolepsy

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

NCT02637076•Centre for Addiction and Mental Health

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

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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
+2 more criteria

Locations (1)

Centre for Addiction and Mental Health (CAMH)

Toronto, Ontario, Canada

Key Dates

Start Date

January 1, 2016

Primary Completion Date

January 23, 2020

Completion Date

January 23, 2020

Last Updated

March 23, 2021

Enrollment

ACTUAL participants

Conditions

Narcolepsy With CataplexyHealthy Controls

Interventions

Xyrem

DRUG

A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy

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Narcolepsy Type 1 (NT1)Narcolepsy With Cataplexy

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RECRUITING

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 23, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Xyrem and Brain Dopamine in Narcolepsy

Inclusion Criteria

Exclusion Criteria

A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

PET Imaging Evaluation of [11C]SY08

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