RECRUITING

A Study to Investigate Efficacy, Safety, Tolerability, and Pharmacokinetics of JZP441 Compared With Placebo in Participants With Narcolepsy Type 1

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Narcolepsy is a sleep disorder in which patients are not able to maintain wakefulness or require treatment to maintain wakefulness during the daytime. Narcolepsy is a lifelong neurologic disease for which no cure has been clinically available. JZP441 is currently being developed for the treatment of narcolepsy type 1 (NT1). This study will assess the safety of efficacy of JZP441 in adult patients with NT1.

Official Title

A Phase 1b, Randomized, Double-blind, Sponsor-Unblinded, Placebo-Controlled 4-Way Crossover Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of JZP441 in Participants With Narcolepsy Type 1

Quick Facts

Study Start:2025-05-13
Study Completion:2026-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06961266

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Clinical Trial Disclosure & Transparency
CONTACT
215-832-3750
ClinicalTrialDisclosure@JazzPharma.com

Principal Investigator

Global Medical Lead
STUDY_DIRECTOR
Jazz Pharmaceuticals

Study Locations (Sites)

Clinical Trial Site
Atlanta, Georgia, 30328
United States
Clinical Trial Site
Cincinnati, Ohio, 45245
United States
Clinical Trial Site
Columbia, South Carolina, 29201
United States

Collaborators and Investigators

Sponsor: Jazz Pharmaceuticals

  • Global Medical Lead, STUDY_DIRECTOR, Jazz Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-13
Study Completion Date2026-04-01

Study Record Updates

Study Start Date2025-05-13
Study Completion Date2026-04-01

Terms related to this study

Keywords Provided by Researchers

  • Narcolepsy Type 1
  • JZP441

Additional Relevant MeSH Terms

  • Narcolepsy