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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03030599
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 23, 2017
First Posted Date  ICMJE January 25, 2017
Last Update Posted Date June 2, 2020
Actual Study Start Date  ICMJE March 14, 2017
Actual Primary Completion Date January 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2020)
The Change in Weekly Number of Cataplexy Attacks [ Time Frame: From the 2 weeks of the open-label Stable Dose Period to the 2 weeks of the Double Blind Randomized- Withdrawal Period) ]
The change in the weekly number of cataplexy attacks from the 2 weeks of the Stable-Dose Period to the 2 weeks of the Double-Blind Randomized-Withdrawal Period will be assessed. For subjects with at least one day of cataplexy attack data, the weekly number of cataplexy attacks will be the average number of daily attacks from days with nonmissing data within the 2 week period, and then multiplied by 7.
Original Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
Change in weekly number of cataplexy attacks [ Time Frame: Two weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2020)
The Change in the Epworth Sleepiness Scale (ESS) Score [ Time Frame: From the end of the Stable Dose Period to the end of the Double Blind Randomized- Withdrawal Period ]
The ESS provides a measure of a person's general level of daytime sleepiness, or their average sleep propensity in daily life.The ESS is a self-administered questionnaire with 8 questions asking the subject how likely they would be to doze off or fall asleep in different situations. Responses range from 0 = would never doze to 3 = high chance of dozing. Subjects will be asked to complete the ESS with regard to the level of sleepiness they experienced over the past 7 days at end of the Stable-Dose Period (Visit 15) and at the end of the Double-Blind Randomized-Withdrawal Period (Visit 16) or Early Termination from the Double-Blind Period.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
Change in the Epworth Sleepiness Scale (ESS) score [ Time Frame: Two weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy
Official Title  ICMJE A Double-Blind, Placebo-Controlled, Randomized-Withdrawal, Multicenter Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy
Brief Summary This is a double-blind, placebo-controlled, randomized-withdrawal, multicenter study of the efficacy and safety of JZP-258.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Narcolepsy With Cataplexy
Intervention  ICMJE
  • Drug: JZP-258
    JZP-258 oral solution 0.5 g/mL, which is equivalent to 0.413 g/mL of oxybate
    Other Name: Xyrem®
  • Other: Placebo
    Matching placebo solution (aqueous solution containing sodium citrate, malic acid, and sucralose; all ingredients were compendial [United States Pharmacopeia/ National Formulary])
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
  • Experimental: JZP-258
    JZP-258
    Intervention: Drug: JZP-258
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2020)
201
Original Estimated Enrollment  ICMJE
 (submitted: January 24, 2017)
130
Actual Study Completion Date  ICMJE July 9, 2019
Actual Primary Completion Date January 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female subjects between 18 and 70 years of age, inclusive.
  2. 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.
  3. 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.
  4. Willing and able to comply with the study design schedule and other requirements.
  5. Willing and able to provide written informed consent.

Exclusion Criteria:

  1. Narcolepsy secondary to another medical condition (e.g., CNS injury or lesion)
  2. 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.
  3. 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).
  4. 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.
  5. Unsafe for the subject to receive placebo treatment for 2 weeks, in the opinion of the Investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czechia,   Finland,   France,   Spain,   United States
Removed Location Countries Croatia,   Germany,   Netherlands,   Poland,   Switzerland,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT03030599
Other Study ID Numbers  ICMJE 15-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jazz Pharmaceuticals
Study Sponsor  ICMJE Jazz Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Director Clinical Trial Disclosure & Transparency Jazz Pharmaceuticals
PRS Account Jazz Pharmaceuticals
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP