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Xyrem and Brain Dopamine in Narcolepsy | Clinical Trials | Clareo Health

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COMPLETEDPhase 4NCT02637076

Xyrem and Brain Dopamine in Narcolepsy

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...

Lead sponsor: Centre for Addiction and Mental Health•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Centre for Addiction and Mental Health

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
•metal implants / objects in the body that may interfere with MRI
•succinic semialdehyde dehydrogenase deficiency

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 23, 2021Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment17

Start dateJan 2016

Last updatedMar 23, 2021

Condition

Narcolepsy With Cataplexy Healthy Controls

Locations shown

Centre for Addiction and Mental Health (CAMH)

Toronto, Ontario

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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: May 10, 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.

View ClinicalTrials.gov Terms and Conditions