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A Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy
This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the efficacy and safety of JZP-258.
Subjects will be transitioned to JZP-258 based on their treatment status at study entry. All subjects will begin JZP-258 treatment at the beginning of this period and continue through Week 12. They will be treated with JZP-258 alone for the final two weeks of this 12-week period. Once the JZP-258 dose has been optimized per the Investigator's judgment, these subjects may enter the 2-week Stable-Dose Period with that dose. Subjects are eligible to enter the Double-Blind Randomized-Withdrawal Period if the dose of JZP-258 remains unchanged during the Stable-Dose Period and, in the judgment of the Investigator, no clinically significant worsening in narcolepsy symptoms or clinically significant adverse events due to JZP-258 treatment have occurred. Subjects will return for a Safety Follow-up visit 2 weeks after the Double-Blind Randomized-Withdrawal Period. Subjects who complete the double-blind treatment period during the Main Study are eligible to enter a 24-week Open-Label Extension. During this period subjects will receive open label JZP-258. Subjects will return for a Safety Follow-up visit 2 weeks after the Open-Label Extension Period.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
March 14, 2017
Primary Completion Date
January 24, 2019
Completion Date
July 10, 2019
Last Updated
November 12, 2020
201
ACTUAL participants
JZP-258
DRUG
Placebo
OTHER
Lead Sponsor
Jazz Pharmaceuticals
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT00345800