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COMPLETED
NCT05875974
PHASE4

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

Sponsor: Jazz Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will assess the safety and efficacy of JZP258 (XYWAV) on sleepiness, polysomnography, and functional outcomes in patients with idiopathic hypersomnia (IH) or narcolepsy.

Official title: A Prospective, Open-Label, Single-Arm, Multicenter Study to Evaluate the Effect of Low-Sodium Oxybate Oral Solution (XYWAV) on Sleepiness, Polysomnography, and Functional Outcomes in Adult Participants Aged 18 to 75 Years With Idiopathic Hypersomnia or Narcolepsy

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

199

Start Date

2023-07-27

Completion Date

2025-03-13

Last Updated

2026-08-27

Healthy Volunteers

No

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. Exploratory Narcolepsy \>9-Gram Cohort: XYWAV titrated to a dosage of \>9 to 12 grams.

Locations (32)

Sleep Disorders Center of Alabama

Birmingham, Alabama, United States

Perseverance Research Center, LLC

Scottsdale, Arizona, United States

Amnova Clinical Research

Irvine, California, United States

Long Beach Research Institute

Lakewood, California, United States

Santa Monica Clinical Trials

Los Angeles, California, United States

Stanford School of Medicine

Redwood City, California, United States

TriValley Sleep Center

San Ramon, California, United States

SDS Clinical Trials, Inc.

Santa Ana, California, United States

Meris Clinical Research, LLC

Brandon, Florida, United States

PharmaDev Clinical Research Institute, LLC

Miami, Florida, United States

Florida Hospital for Children

Winter Park, Florida, United States

NeuroTrials Research, Inc.

Atlanta, Georgia, United States

Centricity Research Rincon - DBA IACT Health Southeast Lung Associates Research

Rincon, Georgia, United States

Neurocare, Inc., dba Neurocare Center for Research

Newtown, Massachusetts, United States

Clinical Neurophysiology Services, P.C.

Sterling Heights, Michigan, United States

St. Lukes Hospital Medical Center

Chesterfield, Missouri, United States

Clinical Research of Gastonia

Gastonia, North Carolina, United States

Stern Research Partners, LLC

Huntersville, North Carolina, United States

CTI Clinical Research Center

Cincinnati, Ohio, United States

Intrepid Research

Cincinnati, Ohio, United States

Cleveland Clinic Main Campus - Clinical Research Unit

Cleveland, Ohio, United States

Ohio Sleep Medicine and Neuroscience Institute

Dublin, Ohio, United States

Abington Neurological Associates, LTD

Abington, Pennsylvania, United States

Geisinger Clinic

Scranton, Pennsylvania, United States

Bogan Sleep Consultants, LLC

Columbia, South Carolina, United States

FutureSearch Trials of Neurology

Austin, Texas, United States

Comprehensive Sleep Medicine Associates

Houston, Texas, United States

Sleep Therapy & Research Center

San Antonio, Texas, United States

Tricoastal Narcolepsy and Sleep Disorders Center

Sugar Land, Texas, United States

Heritage Medical Research Clinic, University of Calgary

Calgary, Alberta, Canada

AMNDX Inc

Markham, Ontario, Canada

Johda Tishon Inc

Toronto, Ontario, Canada