A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy

PHASE4CompletedINTERVENTIONAL
Enrollment

207

Participants

Timeline

Start Date

July 27, 2023

Primary Completion Date

March 13, 2025

Study Completion Date

March 13, 2025

Conditions
Idiopathic HypersomniaNarcolepsy
Interventions
DRUG

JZP258 (XYWAV)

"Narcolepsy Cohort: Initiate dosage per XYWAV label and titrate to effect.~IH Cohort: Initiate dosage per XYWAV label and titrate to effect.~Narcolepsy \>9-Gram Cohort: XYWAV titrated to a dosage of \>9 to 12 grams."

Trial Locations (32)

18510

Geisinger Clinic, Scranton

19001

Abington Neurological Associates, LTD, Abington

28054

Clinical Research of Gastonia, Gastonia

28078

Stern Research Partners, LLC, Huntersville

29201

Bogan Sleep Consultants, LLC, Columbia

30328

NeuroTrials Research, Inc., Atlanta

31326

Centricity Research Rincon - DBA IACT Health Southeast Lung Associates Research, Rincon

32789

Florida Hospital for Children, Winter Park

33176

PharmaDev Clinical Research Institute, LLC, Miami

33511

Meris Clinical Research, LLC, Brandon

35213

Sleep Disorders Center of Alabama, Birmingham

43017

Ohio Sleep Medicine and Neuroscience Institute, Dublin

44195

Cleveland Clinic Main Campus - Clinical Research Unit, Cleveland

45212

CTI Clinical Research Center, Cincinnati

45245

Intrepid Research, Cincinnati

48314

Clinical Neurophysiology Services, P.C., Sterling Heights

63017

St. Lukes Hospital Medical Center, Chesterfield

77030

Comprehensive Sleep Medicine Associates, Houston

77479

Tricoastal Narcolepsy and Sleep Disorders Center, Sugar Land

78229

Sleep Therapy & Research Center, San Antonio

78731

FutureSearch Trials of Neurology, Austin

85253

Perseverance Research Center, LLC, Scottsdale

90025

Santa Monica Clinical Trials, Los Angeles

90805

Long Beach Research Institute, Lakewood

92604

Amnova Clinical Research, Irvine

92705

SDS Clinical Trials, Inc., Santa Ana

94063

Stanford School of Medicine, Redwood City

94583

TriValley Sleep Center, San Ramon

02459

Neurocare, Inc., dba Neurocare Center for Research, Newtown

T2N 4Z6

Heritage Medical Research Clinic, University of Calgary, Calgary

L3R 1A3

AMNDX Inc, Markham

M5S 3A3

Johda Tishon Inc, Toronto

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY