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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

2026-08-19

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 (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