Skip to main content
OpenTrials
Completed

NCT Number: NCT02637076

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Narcolepsy With Cataplexy Disorders of Excessive Somnolence Dyssomnias Healthy Controls Mental Disorders Narcolepsy Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre for Addiction and Mental Health (CAMH)

Toronto, Ontario, M5T 1R8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Xyrem

Drug

single 3.0 gram dose

Other names: Sodium Oxybate, gamma-hydroxybutyrate

Primary outcomes

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

    Time frame: 1 hour post Xyrem

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

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

    Time frame: 1 hour post 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.

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

    Time frame: 7 hours post Xyrem

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

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

    Time frame: 7 hours post 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.

Secondary outcomes

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

    Time frame: 5 hours post single Xyrem dose

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

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

    Time frame: 5 hours post single Xyrem dose

    [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.

  3. Blood Gamma-hydroxybutyrate (GHB) Concentration (AUC)

    Time frame: multiple time points from 0 to 7 hours post-Xyrem

    The concentration of gammahydroxybutyrate in blood of participants who have received a single dose of Xyrem, as measured by Area Under the Curve.

  4. Blood Gamma-hydroxybutyrate (GHB) Cmax

    Time frame: multiple time points from 0 to 7 hours post-Xyrem

    The concentration of gammahydroxybutyrate in blood of participants who have received a single dose of Xyrem as measured by Cmax.

  5. Duration of Drowsiness

    Time frame: observed after receiving single dose of Xyrem, up to 9 hours

    Period of time when the participant was experiencing the sedative action of Xyrem. Data derived from self-report as well as anesthesiologist observation.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 22, 2015
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.