A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy

PHASE3CompletedINTERVENTIONAL
Enrollment

201

Participants

Timeline

Start Date

March 14, 2017

Primary Completion Date

January 24, 2019

Study Completion Date

July 10, 2019

Conditions
Narcolepsy With Cataplexy
Interventions
DRUG

JZP-258

JZP-258 oral solution 0.5 g/mL, which is equivalent to 0.413 g/mL of oxybate

OTHER

Placebo

Matching placebo solution (aqueous solution containing sodium citrate, malic acid, and sucralose; all ingredients were compendial \[United States Pharmacopeia/ National Formulary\])

Trial Locations (25)

2650

UZ Antwerpen, Edegem

3000

UZ Leuven, Leuven

9000

Universitair Ziekenhuis Gent, Ghent

10467

Montefiore/ Sleep-Wake Disorders Center, The Bronx

12004

Hospital General de Castellón, Castelló

20815

Center for Sleep & Wake Disorders, Chevy Chase

28036

Instituto de Investigaciones del Sueño, Madrid

28043

Hospital Vithas Nuestra Señora de America, Madrid

28078

Research Carolina, Huntersville

34295

Hôpital Gui de Chauliac, Montpellier

34741

Pulmonary Disease Specialists, Kissimmee

40218

Kentucky Research Group, Louisville

44195

Cleveland Clinic, Sleep Disorder Center, Cleveland

45245

Intrepid Research, Cincinnati

46804

Fort Wayne Neurological Center, Fort Wayne

59037

Hopital Roger Salengro - CHU Lille, Lille

70800

Fakultni nemocnice Ostrava, Ostrava-Poruba

80301

Colorado Sleep Institute, Boulder

92858

SDS Clinical Trials, Inc., Orange

94305

Stanford Health Services, Stanford

Gastonia Medical Specialty Clinic, Gastonia

128 21

Vseobecna fakultni nemocnice v Praze, Prague

00380

Helsingin Uniklinikka, Vitalmed Oy, Helsinki

08035

Hospital Universitari Vall d'Hebron, Barcelona

08036

Hospital Clinic i Provincial de Barcelona, Barcelona

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY