A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy

Completed · Phase 3 · Has a placebo group

Conditions studied: Narcolepsy With Cataplexy

In brief

This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the efficacy and safety of JZP-258.

Key facts

Study ID

NCT03030599

Run by

Jazz Pharmaceuticals

People needed

201

Starts

2017-03-14

Expected to finish

2019-07-10

Last updated by the study team

2020-11-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects between 18 and 70 years of age, inclusive.
• Have a primary diagnosis of narcolepsy with cataplexy that meets ICSD-3 criteria or DSM-5 criteria, and currently untreated or treated with or without anticataplectics.
• If applicable, treated with a stimulant or alerting agent at unchanged doses for at least 2 months prior to dosing or not treated with a stimulant or alerting agent.
• Willing and able to comply with the study design schedule and other requirements.
• Willing and able to provide written informed consent.

You may not qualify if…

• Narcolepsy secondary to another medical condition (e.g., CNS injury or lesion)
• History or presence of any unstable or clinically significant medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or history or presence of another neurological disorder or surgical history that might affect the subject's safety and/or interfere with the conduct of the study in the opinion of the Investigator.
• Treatment with any central nervous system sedating agents, including but not limited to benzodiazepines, nonbenzodiazepine anxiolytics/ hypnotics/sedatives, neuroleptics, opioids, barbiturates, phenytoin, ethosuximide, or MCT inhibitors, e.g. diclofenac, valproate, ibuprofen, within 2 weeks prior to enrollment (discontinuation for the purpose of study enrollment is permitted only if considered safe by the Investigator and approved by the Medical Monitor).
• Treatment with an antidepressant for cataplexy, if the withdrawal of the antidepressant during cross-titration with JZP-258 might be unsafe due to prior history of depression.
• Unsafe for the subject to receive placebo treatment for 2 weeks, in the opinion of the Investigator.

Where it is running

• SDS Clinical Trials, Inc. — Orange, California, United States
• Stanford Health Services — Stanford, California, United States
• Colorado Sleep Institute — Boulder, Colorado, United States
• Pulmonary Disease Specialists — Kissimmee, Florida, United States
• Fort Wayne Neurological Center — Fort Wayne, Indiana, United States
• Kentucky Research Group — Louisville, Kentucky, United States
• Center for Sleep & Wake Disorders — Chevy Chase, Maryland, United States
• Montefiore/ Sleep-Wake Disorders Center — The Bronx, New York, United States
• Gastonia Medical Specialty Clinic — Gastonia, North Carolina, United States
• Research Carolina — Huntersville, North Carolina, United States
• Intrepid Research — Cincinnati, Ohio, United States
• Cleveland Clinic, Sleep Disorder Center — Cleveland, Ohio, United States
• UZ Antwerpen — Edegem, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• UZ Leuven — Leuven, Belgium
• Fakultni nemocnice Ostrava — Ostrava-Poruba, Czechia
• Vseobecna fakultni nemocnice v Praze — Prague, Czechia
• Helsingin Uniklinikka, Vitalmed Oy — Helsinki, Finland
• Hôpital Gui de Chauliac — Montpellier, Herault, France
• Hopital Roger Salengro - CHU Lille — Lille, France
• Hospital Universitari Vall d'Hebron — Barcelona, Spain
• Hospital Clinic i Provincial de Barcelona — Barcelona, Spain
• Hospital General de Castellón — Castelló, Spain
• Instituto de Investigaciones del Sueño — Madrid, Spain
• Hospital Vithas Nuestra Señora de America — Madrid, Spain

Full record on ClinicalTrials.gov

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