Xyrem and Brain Dopamine in Narcolepsy

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-01-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Narcolepsy With Cataplexy Healthy Controls

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants will be recruited to fill 2 separate study groups: 1) participants with a diagnosis of narcolepsy with cataplexy; 2) healthy controls.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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narcolepsy with cataplexy

patients given single dose of Xyrem

Group Type EXPERIMENTAL

Xyrem

Intervention Type DRUG

single 3.0 gram dose

healthy controls

healthy controls given a single dose of Xyrem

Group Type EXPERIMENTAL

Xyrem

Intervention Type DRUG

single 3.0 gram dose

Interventions

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Xyrem

single 3.0 gram dose

Intervention Type DRUG

Other Intervention Names

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Sodium Oxybate gamma-hydroxybutyrate

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes