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RECRUITING
NCT07625280
PHASE3

A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH

Sponsor: Jazz Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of expanded Xywav dosing regimens in adult participants with narcolepsy or idiopathic hypersomnia (IH).

Official title: A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized-withdrawal Study to Evaluate the Efficacy and Safety of Expanded Dosing Regimens for Xywav in Adult Participants With Narcolepsy or Idiopathic Hypersomnia

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-07-09

Completion Date

2028-01-06

Last Updated

2026-10-08

Healthy Volunteers

No

Interventions

DRUG

Xywav

0.5 g/ml calcium, magnesium, potassium, and sodium oxybates solution taken by mouth

OTHER

Placebo

Placebo solution taken by mouth

Locations (15)

Sleep Disorders Center of Alabama

Birmingham, Alabama, United States

Amnova Clinical Research

Irvine, California, United States

Long Beach Research Institute

Long Beach, California, United States

Santa Monica Clinical Trials

Los Angeles, California, United States

Delta Waves Sleep Disorder and Research Center

Colorado Springs, Colorado, United States

Flourish Research Miami

Miami, Florida, United States

Centricity Research Rincon - DBA IACT Health Southeast Lung Associates Research

Rincon, Georgia, United States

Research Carolina Elite

Denver, North Carolina, United States

Science 37

Morrisville, North Carolina, United States

Intrepid Research

Cincinnati, Ohio, United States

Ohio Sleep Medicine and Neuroscience Institute

Dublin, Ohio, United States

K2 Medical Research Nashville

Nashville, Tennessee, United States

Future Search Trials - Austin Neurology

Austin, Texas, United States

FutureSearch Trials of Dallas

Dallas, Texas, United States

Tricoastal Narcolepsy and Sleep Disorders Center

Sugar Land, Texas, United States