RecruitingPhase 3NCT07625280

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

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


Sponsor

Jazz Pharmaceuticals

Enrollment

120 participants

Start Date

Jul 9, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo and a drug called Xywav for people with idiopathic hypersomnia and narcolepsy. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXywav

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

OTHERPlacebo

Placebo solution taken by mouth


Locations(3)

Santa Monica Clinical Trials

Los Angeles, California, United States

Intrepid Research

Cincinnati, Ohio, United States

Ohio Sleep Medicine and Neuroscience Institute

Dublin, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT07625280


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