CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 17 enrolled
Drug / intervention
Xyremdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02637076
NCT02637076Phase 4Completed
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Does Xyrem Influence Brain Dopamine in Patients With Narcolepsy? A PET Imaging Investigation

Centre for Addiction and Mental Health·interventional·Posted Dec 22, 2015·Updated Mar 23, 2021

In Brief

A Phase 4 clinical trial evaluating Xyrem for Narcolepsy With Cataplexy and Healthy Controls. Completed, enrolled 17 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNarcolepsy With Cataplexy, Healthy Controls
CountriesCanada
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 22, 2015
Enrollment StartJan 1, 2016
Primary CompletionJan 23, 2020
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 10.5 years ago

Interventions

Xyremdrug

single 3.0 gram dose