Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy

PHASE3CompletedINTERVENTIONAL
Enrollment

212

Participants

Timeline

Start Date

November 17, 2016

Primary Completion Date

March 25, 2020

Study Completion Date

March 25, 2020

Conditions
Excessive Daytime SleepinessCataplexyNarcolepsy
Interventions
DRUG

FT218

DRUG

Placebo

Trial Locations (57)

2037

NHMRC CEntre for Translational Sleep and Circadian Neurobiology, Sydney

3002

Melbourne Sleep Disorders Centre, Melbourne

5400

CIUSS de Nord-de-I'ile-de- Montreal- Hopital de Sacre-Coeur de Montreal, Montreal

10117

Charit Universittsmedizin Berlin, Berlin

10467

Montefiore Sleep-Wake Disorders Center, The Bronx

17822

Geisinger Medical Center, Danville

19053

Somni bene GmbH, Schwerin

20815

Center for Sleep and Wake Disorders, Chevy Chase

28078

Research Carolina of Huntersville, Huntersville

29201

SleepMed Of South Carolina, Columbia

30281

Clinical Research Institute, Stockbridge

30342

NeuroTrials Research Inc, Atlanta

32789

FL Pediatric REsearch Institute, Winter Park

Florida Pulmonary Research Institute LLC, Winter Park

33176

Sleep Medicine Specialists of South Florida, Miami

34131

Hephata Klinik, Schwalmstadt

34295

Hospital Gui-de-de-Chauliac, Montpellier

34741

Pulmonary Disease Specialist, PA, Kissimmee

35213

Sleep Disorders Center of Alabama, Birmingham

36207

Pinnacle Research Group LLC, Anniston

43017

Ohio Sleep Medicine Institute, Dublin

44106

University Hospitals Case Medical Center, Cleveland

45245

Sleep Management Institute Intrepid Research, Cincinnati

61637

OSF Healthcare Saint Francis Medical Center, Peoria

63017

Chesterfield

63143

St Louis

72205

Baptist Health Center for Clinical Research, Little Rock

75019

INSERM - Centre d'Investigation Clinque Hopital Robert Debre, Paris

77063

Sleep and Neurology Consultants, Houston

78229

Sleep Therapy Research Center, San Antonio

80301

Alpine Research Center, Boulder

94063

Stanford Sleep Medicine, Redwood City

94501

California Center for Sleep Disorders, Alameda

212821

Vseobecna Facultni Nemocnice, Prague

938043

CHU Michallon, Grenoble

AL 36832

University Sleep Disorder Center, Auburn

CA 92705

SDS Clinical Trials Inc, Santa Ana

06473

Yale-New Haven Hospital's Sleep Medicine Center, North Haven

FL 33126

Sleep Medicine Specialist of South Florida, Miami

FL 32405

NeuroMedical Research Institute/Global Research Holdings, LLC, Panama City

GA 30342

Sleep Disorders Center of Georgia, Atlanta

IN 46804

Fort Wayne Neurological Center, Fort Wayne

KY40218

Norton Clinical Research Group, Louisville

MA 2747

Infinity Medical Research, North Dartmouth

NY 1040

Northwell Health, New Hyde Park

NY10019

Clinilabs Drug Development Corporation, New York

NC 27612

Wake Research Associates, LLC, Raleigh

SC 29425

Medical University of South Carolina - Institute of Psychiatry, Charleston

NSW 2145

Westmead Hospital, Sydney

QLD 4102

Princess Alexandra Hospital, Brisbane

SA 5011

Queen Elizabeth Hospital, Adelaide

SA 5042

Flinders Medical Centre, Adelaide

T2X 2A8

Somni Research Inc. Calgary, Calgary

BC V1Y 1Z9

Okanagan Clinical Trials Ltd, Kelowna

P2A 3A4

West Parry Sound Health Center, Parry Sound

L3R 1A3

Somni Research Inc, Toronto

M5G 1N8

Paediatric Sleep Research Inc, Toronto

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Avadel

INDUSTRY

NCT02720744 - Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy | Biotech Hunter | Biotech Hunter