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"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"

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ClinicalTrials.gov Identifier: NCT02348593
Recruitment Status : Completed
First Posted : January 28, 2015
Results First Posted : July 23, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE January 15, 2015
First Posted Date  ICMJE January 28, 2015
Results First Submitted Date  ICMJE April 19, 2019
Results First Posted Date  ICMJE July 23, 2019
Last Update Posted Date July 23, 2019
Actual Study Start Date  ICMJE May 2015
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2019)
  • Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]
    Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from baseline to Week 12. MWT sleep latency ranges from 0 to 40 minutes, with higher scores indicating greater ability to stay awake; a positive change from baseline represents improvement in the sleep latency time. Mean sleep latency defined as the average of the first 4 MWT trials, if 3 or 4 of them are non-missing.
  • Change in ESS Score From Baseline to Week 12 [ Time Frame: Baseline to Week 12 ]
    Change in Epworth Sleepiness Scale (ESS) score from Baseline to Week 12. A negative change from baseline represents improvement in excessive sleepiness. The ESS is a self-administered questionnaire with 8 questions. Each activity is scored on a scale ranging from 0-3, with 0 = would never fall asleep, and 3 = high chance of falling asleep. The total score ranges from 0-24, with a higher number representing an increased propensity for sleepiness. An analysis of covariance (ANCOVA) was used for the analysis of ESS scores. The response variable was the change in ESS score from baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2015)
  • Maintenance of Wakefulness Test (MWT): Change in the mean sleep latency time (in minutes) as determined from the first four trials of a 40-minute MWT from Baseline to Week 12 [ Time Frame: 12 Weeks ]
  • Epworth Sleepiness Scale (ESS): Change in ESS score from Baseline to Week 12 [ Time Frame: 12 Weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2019)
  • Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12 [ Time Frame: Baseline to Week 12 ]
    Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12. PGIc was rated by subjects and measures the change in their condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse
  • Change in Sleep Latency Time on MWT Trial 1 at Week 12 [ Time Frame: Change from baseline for sleep latency in MWT during trial 1 at week 12 ]
    Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
  • Change in Sleep Latency Time on MWT Trial 2 at Week 12 [ Time Frame: Change from baseline for sleep latency in MWT during trial 2 at week 12 ]
    Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
  • Change in Sleep Latency Time on MWT Trial 3 at Week 12 [ Time Frame: Change from baseline for sleep latency in MWT during trial 3 at week 12 ]
    Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
  • Change in Sleep Latency Time on MWT Trial 4 at Week 12 [ Time Frame: Change from baseline for sleep latency in MWT during trial 4 at week 12 ]
    Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
  • Change in Sleep Latency Time on MWT Trial 5 at Week 12 [ Time Frame: Change from baseline for sleep latency in MWT during trial 5 at week 12 ]
    Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
  • Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-Minute MWT From Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
    Change in mean sleep latency time (in minutes) as determined from the first 4 trials of a 40-minute MWT from Baseline to Week 4.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2015)
Patient Global Impression of change (PGIc): Percentage of subjects reported as improved (minimally, much, or very much) on the PGIc at Week 12 [ Time Frame: 12 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE "Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
Official Title  ICMJE A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy
Brief Summary This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.
Detailed Description Not Provided
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
Intervention  ICMJE
  • Drug: JZP-110
  • Drug: Placebo oral tablet
Study Arms  ICMJE
  • Active Comparator: 75 mg of JZP-110
    Once Daily Dosing
    Intervention: Drug: JZP-110
  • Active Comparator: 150 mg JZP-110
    Once Daily Dosing
    Intervention: Drug: JZP-110
  • Active Comparator: 300 mg of JZP-110
    Once Daily Dosing
    Intervention: Drug: JZP-110
  • Placebo Comparator: Placebo
    Once Daily Dosing
    Intervention: Drug: Placebo oral tablet
Publications * Emsellem HA, Thorpy MJ, Lammers GJ, Shapiro CM, Mayer G, Plazzi G, Chen D, Carter LP, Villa KF, Lee L, Menno D, Black J, Dauvilliers Y. Measures of functional outcomes, work productivity, and quality of life from a randomized, phase 3 study of solriamfetol in participants with narcolepsy. Sleep Med. 2020 Mar;67:128-136. doi: 10.1016/j.sleep.2019.11.1250. Epub 2019 Dec 4.

*   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: October 19, 2017)
239
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2015)
240
Actual Study Completion Date  ICMJE February 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Major Inclusion Criteria:

  1. Males and females between 18 and 75 years of age, inclusive
  2. Diagnosis of narcolepsy according to ICSD-3 or DSM-5 criteria
  3. Body mass index from 18 to <45 kg/m2
  4. Consent to use a medically acceptable method of contraception
  5. Willing and able to provide written informed consent

Major Exclusion Criteria:

  1. Female subjects who are pregnant, nursing, or lactating
  2. Moderate or severe sleep apnea on the baseline PSG.
  3. Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
  4. History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
  5. History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the subject or interfere with study efficacy, safety, PK assessments, or the ability of the subject to complete the trial per the judgment of the Investigator
  6. History of bariatric surgery within the past year or a history of any gastic bypass procedure
  7. Presence or history of significant cardiovascular disease
  8. Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
  9. Use of any medications that could affect the evaluation of cataplexy
  10. Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
  11. Previous exposure to or participation in a previous clinical trial of JZP-110 (ADX-N05, R228060, YKP10A)
  12. History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 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 Canada,   Finland,   France,   Germany,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02348593
Other Study ID Numbers  ICMJE 14-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jazz Pharmaceuticals
Study Sponsor  ICMJE Jazz Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jazz Pharmaceuticals
Verification Date July 2019

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