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Completed

NCT Number: NCT02348593

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

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.

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Key information

Conditions

Narcolepsy Disorders of Excessive Somnolence Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

London Health Sciences Centre, London, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Major Inclusion Criteria:

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

Major Exclusion Criteria:

  • Female subjects who are pregnant, nursing, or lactating
  • Moderate or severe sleep apnea on the baseline PSG.
  • Any other clinically relevant medical, behavioral, or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
  • History or presence of bipolar disorder, bipolar related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5 criteria
  • 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
  • History of bariatric surgery within the past year or a history of any gastic bypass procedure
  • Presence or history of significant cardiovascular disease
  • Use of any over-the-counter (OTC) or prescription medications that could affect the evaluation of excessive sleepiness
  • Use of any medications that could affect the evaluation of cataplexy
  • Received an investigational drug in the past 30 days or five half-lives (whichever is longer)
  • Previous exposure to or participation in a previous clinical trial of JZP-110 (ADX-N05, R228060, YKP10A)
  • History of phenylketonuria (PKU) or history of hypersensitivity to phenylalanine-derived products

Treatment and study plan

JZP-110

Drug

Placebo oral tablet

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Jazz Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 28, 2015
Registry last updated
Jul 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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