A Multicenter Study of the Efficacy & Safety of Xyrem With an Open- Label

Updated 06/21/2024

Status Completed

Clinical Trial Summary

The purpose of this trial is to assess the efficacy and safety of Xyrem in pediatrics subjects with narcolepsy that includes cataplexy.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02221869
Study type	Interventional
Source	Jazz Pharmaceuticals
Contact
Status	Completed
Phase	Phase 3
Start date	October 1, 2014
Completion date	January 25, 2019

See also
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	Suspended	`NCT04419792` - 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'
	Completed	`NCT03030599` - A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy	Phase 3
	Active, not recruiting	`NCT02611687` - Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period	Phase 3
	Completed	`NCT04306952` - Awareness and Self-Compassion Enhancing Narcolepsy Treatment	N/A
	Not yet recruiting	`NCT06383806` - Decreasing Nightmares in Adults With Narcolepsy	N/A
	Not yet recruiting	`NCT05914194` - A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1	Phase 3
	Completed	`NCT02637076` - Xyrem and Brain Dopamine in Narcolepsy	Phase 4
	Completed	`NCT05709873` - Narcolepsy Nightmare Study	N/A
	Completed	`NCT01800045` - Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP)	Phase 3
	Completed	`NCT00345800` - Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes	Phase 1
	No longer available	`NCT03433131` - Expanded Access Program to Provide Treatment With Pitolisant to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy