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

Phase 3

Completed

• Conditions: Narcolepsy
• Interventions: Drug: JZP-110; Drug: Placebo oral tablet

• Registration Number: NCT02348593
• Lead Sponsor: Jazz Pharmaceuticals

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 available

Study Timeline

• Study First Submitted: 2015-01-15
• Study First Submitted QC: 2015-01-22
• Study First Posted: 2015-01-28
• Study Start: 2015-05
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Disposition First Submitted: 2018-01-19
• Disposition First Submitted QC: 2018-01-19
• Disposition First Posted: 2018-01-25
• Results First Submitted: 2019-04-19
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-21
• Last Update Submitted: 2019-07-21
• Results First Posted: 2019-07-23
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
150 mg JZP-110	JZP-110	Once Daily Dosing
300 mg of JZP-110	JZP-110	Once Daily Dosing
Placebo	Placebo oral tablet	Once Daily Dosing
75 mg of JZP-110	JZP-110	Once Daily Dosing

Primary Outcome Measures

Name	Time	Method
Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12	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	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

Name	Time	Method
Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12	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	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	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	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	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	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	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.

Trial Locations

Locations (59)

Sleep Disorders Center of Alabama; 🇺🇸 Birmingham, Alabama, United States

Pulmonary Associates; 🇺🇸 Glendale, Arizona, United States

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Preferred Research Partners; 🇺🇸 Little Rock, Arkansas, United States

So Cal Institute For Respiratory Diseases, Inc.; 🇺🇸 Los Angeles, California, United States

Pacific Sleep Medicine; 🇺🇸 Oceanside, California, United States

SDS Clinical Trials; 🇺🇸 Orange, California, United States

Stanford University Center for Narcolepsy; 🇺🇸 Redwood City, California, United States

Pacific Research Network, Inc.; 🇺🇸 San Diego, California, United States

Critical Care Pulmonary & Sleep Associates, LLC; 🇺🇸 Lakewood, Colorado, United States

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