201
Participants
Start Date
March 14, 2017
Primary Completion Date
January 24, 2019
Study Completion Date
July 10, 2019
JZP-258
JZP-258 oral solution 0.5 g/mL, which is equivalent to 0.413 g/mL of oxybate
Placebo
Matching placebo solution (aqueous solution containing sodium citrate, malic acid, and sucralose; all ingredients were compendial \[United States Pharmacopeia/ National Formulary\])
UZ Antwerpen, Edegem
UZ Leuven, Leuven
Universitair Ziekenhuis Gent, Ghent
Montefiore/ Sleep-Wake Disorders Center, The Bronx
Hospital General de Castellón, Castelló
Center for Sleep & Wake Disorders, Chevy Chase
Instituto de Investigaciones del Sueño, Madrid
Hospital Vithas Nuestra Señora de America, Madrid
Research Carolina, Huntersville
Hôpital Gui de Chauliac, Montpellier
Pulmonary Disease Specialists, Kissimmee
Kentucky Research Group, Louisville
Cleveland Clinic, Sleep Disorder Center, Cleveland
Intrepid Research, Cincinnati
Fort Wayne Neurological Center, Fort Wayne
Hopital Roger Salengro - CHU Lille, Lille
Fakultni nemocnice Ostrava, Ostrava-Poruba
Colorado Sleep Institute, Boulder
SDS Clinical Trials, Inc., Orange
Stanford Health Services, Stanford
Gastonia Medical Specialty Clinic, Gastonia
Vseobecna fakultni nemocnice v Praze, Prague
Helsingin Uniklinikka, Vitalmed Oy, Helsinki
Hospital Universitari Vall d'Hebron, Barcelona
Hospital Clinic i Provincial de Barcelona, Barcelona
Lead Sponsor
Jazz Pharmaceuticals
INDUSTRY