A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension

PHASE3CompletedINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

November 27, 2018

Primary Completion Date

June 12, 2020

Study Completion Date

December 18, 2020

Conditions
Idiopathic Hypersomnia
Interventions
DRUG

JZP-258

Participants randomized to JZP-258 will receive the dose taken at the end of the Stable Dose Period.

DRUG

Placebo Oral Solution

Participants randomized to Placebo will receive an oral solution at a volume and regimen equivalent to the JZP-258 dose taken at the end of the Stable Dose Period.

Trial Locations (63)

2650

Antwerp University Hospital, Edegem

3570

Anima Research Center, Alken

5000

CHU UCL Namur site de Sainte Elisabeth, Namur

10467

Montefiore Medical Center/Sleep-Wake Disorders Center, The Bronx

17822

Geisinger Medical Center, Danville

19090

Abington Neurological Associates, Willow Grove

20815

Center for Sleep & Wake Disorders, Chevy Chase

27607

Raleigh Neurology Associates, Raleigh

28040

Fundacion Jimenez Diaz, Madrid

Hospital Universitario Clinico San Carlos, Madrid

28043

Hospital Vithas Nuestra Señora de America, Madrid

28054

Clinical Research of Gastonia, Gastonia

28078

Research Carolina, Huntersville

28117

Clinical Research of Lake Norman, Mooresville

28207

American Health Research, Charlotte

29201

Bogan Sleep Consultants, LLC, Columbia

29425

Medical University of South Carolina, Charleston

29464

Clinical Research of Charleston, Mt. Pleasant

30281

SleepCare Research Institute d/b/a Clinical Research, Stockbridge

30342

NeuroTrials Research, Atlanta

31210

Sleep Practitioners, LLC, Macon

33135

Suncoast Research Group, Miami

33184

Bio-Medical Research, LLC, Miami

33511

PAB Clinical Research, Brandon

33603

Clinical Research of West Florida, Inc., Tampa

34295

Hopital Gui de Chauliac, Montpellier

35213

Sleep Disorders Center of Alabama, Birmingham

35243

Wright Clinical Research, LLC, Birmingham

36608

Coastal Clinical Research, Mobile

38018

Neurology Clinic, PC, Cordova

38043

CHU de Grenoble - Hôpital Michallon, Grenoble

43017

Ohio Sleep Medicine and Neuroscience Institute, Dublin

44093

CHU Nantes - Hopital Nord Laënnec, Nantes

44195

The Cleveland Clinic Foundation, Cleveland

45245

Intrepid Research, Cincinnati

46026

Hospital Universitari i Politecnic La Fe, Valencia

48314

Clinical Neurophysiology Services, P.C., Sterling Heights

49007

Bronson Methodist Hospital, Kalamazoo

50333

Fakultni nemocnice Hradec Kralove, Hradec Králové

55435

Minnesota Lung Center, Minneapolis

59037

Hopital Roger Salengro, Lille

63146

Clayton Sleep Institute, LLC, St Louis

73112

Lynne Health Science Institute, Oklahoma City

75651

Hopital Pitie-Salpetriere, Paris

78229

Sleep Therapy & Research Center, San Antonio

78731

FutureSearch Trials of Neurology, Austin

80301

Alpine Clinical Research Center, Boulder

80918

Delta Waves, Inc., Colorado Springs

85054

Mayo Clinic Building, Phoenix

90048

Southern California Institute for Respiratory Diseases, Inc., Los Angeles

92705

SDS Clinical Trials, Inc., Santa Ana

94063

Stanford Sleep Medicine Center, Redwood City

01199

Baystate Wesson Sleep Clinic, Springfield

370 01

Nemocnice Ceske Budejovice a.s., České Budějovice

128 21

Vseobecna fakultni nemocnice v Praze, Prague

00240

VitalMed Oy, Helsinki

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

61-505

Osrodek Badan Klinicznych CROMED, Poznan

02-957

lnstytut Psychiatrii i Neurologii, Zaklad Neurofizjologii Klinicznej, Warsaw

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic de Barcelona, Barcelona

01009

Hospital Universitario Araba, Vitoria-Gasteiz

EH16 4SA

Royal Infirmary of Edinburgh, Edinburgh

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY