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Central Nervous System Depressant

Xyrem and Brain Dopamine in Narcolepsy

Phase 4
Waitlist Available
Led By Stephen J Kish, Ph.D.
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* current diagnosis of narcolepsy with cataplexy OR healthy control
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up observed after receiving single dose of xyrem, up to 9 hours
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
All Individual Drugs Already Approved

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.

Eligible Conditions
  • Narcolepsy
  • Healthy Controls

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~observed after receiving single dose of xyrem, up to 9 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and observed after receiving single dose of xyrem, up to 9 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
% Change in PET [C11]Raclopride Binding From Baseline After Single Dose of Xyrem
[C-11]Raclopride BPND at 1 Hour Post Xyrem
[C-11]Raclopride BPND at 7 Hours Post Xyrem
Secondary study objectives
Positron-Emission Tomography
Blood Gamma-hydroxybutyrate (GHB) Cmax
Blood Gamma-hydroxybutyrate (GHB) Concentration (AUC)
+2 more

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Group I: narcolepsy with cataplexyExperimental Treatment1 Intervention
patients given single dose of Xyrem
Group II: healthy controlsExperimental Treatment1 Intervention
healthy controls given a single dose of Xyrem
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium oxybate
FDA approved

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
374 Previous Clinical Trials
82,644 Total Patients Enrolled
Stephen J Kish, Ph.D.Principal InvestigatorCentre for Addiction and Mental Health
~2 spots leftby Dec 2025
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