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

ClinicalTrials.gov ID: NCT07625280

Public ClinicalTrials.gov record NCT07625280. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 20, 2026, 6:27 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID: NCT07625280
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Jazz Pharmaceuticals; Industry
Enrollment: 120 participants

Conditions and interventions

Conditions

Interventions

Xywav Drug
Placebo Other

Drug · Other

Eligibility (public fields only)

Age range: 18 Years to 75 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 9, 2026 (Actual)
Primary completion: Dec 23, 2027 (Estimated)
Completion: Jan 6, 2028 (Estimated)
Last update posted: Oct 8, 2026

2026 – 2028

United States locations

U.S. sites: 15
U.S. states: 9
U.S. cities: 15

Facility	City	State	ZIP	Site status
Sleep Disorders Center of Alabama	Birmingham	Alabama	35213	Recruiting
Amnova Clinical Research	Irvine	California	92604	Recruiting
Long Beach Research Institute	Long Beach	California	90805	Recruiting
Santa Monica Clinical Trials	Los Angeles	California	90025	Recruiting
Delta Waves Sleep Disorder and Research Center	Colorado Springs	Colorado	80918	Recruiting
Flourish Research Miami	Miami	Florida	33135	Recruiting
Centricity Research Rincon - DBA IACT Health Southeast Lung Associates Research	Rincon	Georgia	31326	Recruiting
Research Carolina Elite	Denver	North Carolina	28037	Recruiting
Science 37	Morrisville	North Carolina	27560	Recruiting
Intrepid Research	Cincinnati	Ohio	45245	Recruiting
Ohio Sleep Medicine and Neuroscience Institute	Dublin	Ohio	43017	Recruiting
K2 Medical Research Nashville	Nashville	Tennessee	37204	Recruiting
Future Search Trials - Austin Neurology	Austin	Texas	78731	Recruiting
FutureSearch Trials of Dallas	Dallas	Texas	75251	Recruiting
Tricoastal Narcolepsy and Sleep Disorders Center	Sugar Land	Texas	77478	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07625280, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 8, 2026 · Synced Oct 20, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07625280 live on ClinicalTrials.gov.

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