Xyrem and Brain Dopamine in Narcolepsy

Centre for Addiction and Mental Health17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Narcolepsy With Cataplexy Healthy Controls

Interventions

XyremDRUG

single 3.0 gram dose

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Centre for Addiction and Mental Health (CAMH)

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

[C-11]Raclopride BPND at 1 Hour Post Xyrem

BPND (Binding Potential) of \[C-11\]raclopride measures 1 hour after taking a single 3g dose of Xyrem.

Time frame: 1 hour post Xyrem

% Change in PET [C11]Raclopride Binding From Baseline After Single Dose of Xyrem

\[C-11\] raclopride is a radioligand that binds to the D2/3 dopamine receptor in the dopamine-rich striatum and which is sensitive to dopamine occupancy. % change was calculated as follows: (1 hour BPND - baseline BPND)/baseline BPND \*100; Mean % change represents the mean of each participant's individual % change within the group.

Time frame: 1 hour post Xyrem

[C-11]Raclopride BPND at 7 Hours Post Xyrem

BPND (Binding Potential) of \[C-11\]raclopride measures 7 hours after taking a single 3g dose of Xyrem.

Time frame: 7 hours post Xyrem

% Change in PET [C11]Raclopride Binding From Baseline After Single Dose of Xyrem

\[C-11\] raclopride is a radioligand that binds to the D2/3 dopamine receptor in the dopamine-rich striatum and which is sensitive to dopamine occupancy. % change was calculated as follows: (7 hours BPND - baseline BPND)/baseline BPND \*100; Mean % change represents the mean of each participant's individual % change within the group.

Time frame: 7 hours post Xyrem

Secondary Outcomes

[C-11]DTBZ BPND at 5 Hours Post Xyrem

Measurement of \[C-11\]DTBZ 5 hours after taking a single dose of 3g Xyrem

Time frame: 5 hours post single Xyrem dose

% Change in PET [C-11] Dihydrotetrabenazine (DTBZ) Binding From Baseline to Five Hours Post Xyrem

\[C-11\] DTBZ is a radioligand that binds to the vesicular monoamine transporter and which is sensitive to dopamine occupancy. % change was calculated as follows: (5 hour BPND - baseline BPND)/baseline BPND \*100; Mean % change represents the mean of each participant's individual % change within the group.

Data from ClinicalTrials.gov

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