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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Narcolepsy Drug: JZP-110 Drug: Placebo oral tablet Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 75 mg of JZP-110
Once Daily Dosing
 Drug: JZP-110
Active Comparator: 150 mg JZP-110
Once Daily Dosing
 Drug: JZP-110
Active Comparator: 300 mg of JZP-110
Once Daily Dosing
 Drug: JZP-110
Placebo Comparator: Placebo
Once Daily Dosing
 Drug: Placebo oral tablet


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.



Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02348593


Locations
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Sponsors and Collaborators
Jazz Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Jazz Pharmaceuticals:
Study Protocol  [PDF] February 8, 2016
Statistical Analysis Plan  [PDF] March 2, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02348593    
Other Study ID Numbers: 14-002
First Posted: January 28, 2015    Key Record Dates
Results First Posted: July 23, 2019
Last Update Posted: July 23, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Narcolepsy
Sleepiness
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
 Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders