A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy

PHASE3CompletedINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

October 1, 2014

Primary Completion Date

February 28, 2017

Study Completion Date

January 25, 2019

Conditions
Narcolepsy With Cataplexy
Interventions
DRUG

Xyrem

Trial Locations (20)

10467

Montefiore Medical Center, The Bronx

23507

Children's Hospital of The King's Daughters, Norfolk

27710

Duke Children's Hospital, Durham

28078

ARSM Research, LLC, Huntersville

29201

SleepMed of SC, Columbia

29615

Greenville Health System, Greenville

38105

UT/LeBonheur Neuroscience Institute, Memphis

40139

Dipartimento di Scienze Biomediche e Biomotorie, Bologna

43205

Nationwide Children's Hospital, Columbus

44106

University Hospitals Cleveland Medical Center, Cleveland

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

48109

The U-M Sleep Disorders Center, Ann Arbor

60611

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

75019

Hospital Robert Debre, Paris

77063

Todd Swick, MD, PA, Houston

90806

Miller Children's Hospital - Long Beach, Long Beach

92868

SDS Clinical Trials, Inc., Orange

94063

Stanford Sleep Medicine Center, Redwood City

98105

Seattle Children's Hospital, Seattle

2103 SW

Sleep Wake Center SEIN Heemstede, Heemstede

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY