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Central Nervous System Depressant

narcolepsy with cataplexy for 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

Study 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
% 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 outcome measures
Positron-Emission Tomography
Blood Gamma-hydroxybutyrate (GHB) Cmax
Blood Gamma-hydroxybutyrate (GHB) Concentration (AUC)
+2 more

Side effects data

From 2020 Phase 4 trial • 17 Patients • NCT02637076
20%
Nausea
7%
Euphoria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Healthy Controls
Narcolepsy With Cataplexy

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
358 Previous Clinical Trials
82,371 Total Patients Enrolled
Stephen J Kish, Ph.D.Principal InvestigatorCentre for Addiction and Mental Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Xyrem and Brain Dopamine in Narcolepsy
Stephen Kish 2016. "Xyrem and Brain Dopamine in Narcolepsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02637076.
~2 spots leftby May 2025
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