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

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: 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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Narcolepsy
Interventions Drug: JZP-110
Drug: Placebo oral tablet
Enrollment 239
Recruitment Details  
Pre-assignment Details 239 subjects were randomized in a 1:1:1:1 ratio to receive placebo, 75 mg JZP-110, 150 mg JZP-110 or 300 mg JZP-110. 236 subjects received at least 1 dose of study medication and comprised the Safety Population; the remaining 3 subjects were randomized in error (did not receive study medication) and were excluded from the Safety Population.
Arm/Group Title 75 mg of JZP-110 150 mg JZP-110 300 mg of JZP-110 Placebo
Hide Arm/Group Description 75 mg JZP-110 administered orally, QD, for the 12-week treatment phase. Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase and then received 150 mg JZP-110 starting on Day 4, administered orally, QD. Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase, and received 300 mg JZP-110 starting on Day 4, administered orally, QD. Placebo administered orally, QD, for the 12 week treatment phase.
Period Title: Overall Study
Started 59 59 59 59
Completed 49 51 43 52
Not Completed 10 8 16 7
Arm/Group Title 75 mg of JZP-110 150 mg JZP-110 300 mg of JZP-110 Placebo Total
Hide Arm/Group Description 75 mg JZP-110 administered orally, QD, for the 12-week treatment phase. Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase and then received 150 mg JZP-110 starting on Day 4, administered orally, QD. Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase, and received 300 mg JZP-110 starting on Day 4, administered orally, QD. Placebo administered orally, QD, for the 12 week treatment phase. Total of all reporting groups
Overall Number of Baseline Participants 59 59 59 59 236
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 59 participants 59 participants 59 participants 236 participants
36.5  (12.78) 38.1  (13.00) 34.3  (11.51) 36.0  (15.17) 36.3  (12.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 59 participants 59 participants 236 participants
Female
37
  62.7%
42
  71.2%
40
  67.8%
35
  59.3%
154
  65.3%
Male
22
  37.3%
17
  28.8%
19
  32.2%
24
  40.7%
82
  34.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 59 participants 59 participants 236 participants
American Indian or Alaska Native
0
   0.0%
1
   1.7%
1
   1.7%
0
   0.0%
2
   0.8%
Asian
0
   0.0%
3
   5.1%
3
   5.1%
0
   0.0%
6
   2.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   1.7%
0
   0.0%
1
   0.4%
Black or African American
12
  20.3%
6
  10.2%
5
   8.5%
10
  16.9%
33
  14.0%
White
46
  78.0%
48
  81.4%
48
  81.4%
47
  79.7%
189
  80.1%
More than one race
1
   1.7%
1
   1.7%
1
   1.7%
2
   3.4%
5
   2.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change in Maintenance of Wakefulness Test (MWT) From Baseline to Week 12
Hide Description 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.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.
Arm/Group Title Placebo 75 mg of JZP-110 150 mg JZP-110 300 mg of JZP-110
Hide Arm/Group Description:
Placebo administered orally, QD, for the 12 week treatment phase.
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase and then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase, and received 300 mg JZP-110 starting on Day 4, administered orally, QD.
Overall Number of Participants Analyzed 58 59 55 59
Least Squares Mean (Standard Error)
Unit of Measure: minutes
2.12  (1.289) 4.74  (1.335) 9.77  (1.327) 12.27  (1.389)
2.Primary Outcome
Title Change in ESS Score From Baseline to Week 12
Hide Description

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.

Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.
Arm/Group Title Placebo 75 mg of JZP-110 150 mg JZP-110 300 mg of JZP-110
Hide Arm/Group Description:
Placebo administered orally, QD, for the 12 week treatment phase.
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase and then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase, and received 300 mg JZP-110 starting on Day 4, administered orally, QD.
Overall Number of Participants Analyzed 58 59 55 59
Least Squares Mean (Standard Error)
Unit of Measure: points on a scale
-1.6  (0.65) -3.8  (0.67) -5.4  (0.66) -6.4  (0.68)
3.Secondary Outcome
Title Subjects Reported Improved on the Patient Global Impression of Change (PGIc) at Week 12
Hide Description 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
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.
Arm/Group Title Placebo 75 mg of JZP-110 150 mg JZP-110 300 mg of JZP-110
Hide Arm/Group Description:
Placebo administered orally, QD, for the 12 week treatment phase.
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase and then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase, and received 300 mg JZP-110 starting on Day 4, administered orally, QD.
Overall Number of Participants Analyzed 58 59 55 59
Measure Type: Number
Unit of Measure: percentage of subjects
39.7 67.8 78.2 84.7
4.Secondary Outcome
Title Change in Sleep Latency Time on MWT Trial 1 at Week 12
Hide Description Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Time Frame Change from baseline for sleep latency in MWT during trial 1 at week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.
Arm/Group Title Placebo 75 mg of JZP-110 150 mg JZP-110 300 mg of JZP-110
Hide Arm/Group Description:
Placebo administered orally, QD, for the 12 week treatment phase.
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase and then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase, and received 300 mg JZP-110 starting on Day 4, administered orally, QD.
Overall Number of Participants Analyzed 58 59 55 59
Least Squares Mean (Standard Error)
Unit of Measure: minutes
-0.55  (4.658) 3.27  (1.725) 9.87  (1.713) 9.91  (1.841)
5.Secondary Outcome
Title Change in Sleep Latency Time on MWT Trial 2 at Week 12
Hide Description Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Time Frame Change from baseline for sleep latency in MWT during trial 2 at week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.
Arm/Group Title Placebo 75 mg of JZP-110 150 mg JZP-110 300 mg of JZP-110
Hide Arm/Group Description:
Placebo administered orally, QD, for the 12 week treatment phase.
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase and then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase, and received 300 mg JZP-110 starting on Day 4, administered orally, QD.
Overall Number of Participants Analyzed 58 59 55 59
Least Squares Mean (Standard Error)
Unit of Measure: minutes
1.41  (1.638) 5.70  (1.697) 9.46  (1.674) 14.50  (1.835)
6.Secondary Outcome
Title Change in Sleep Latency Time on MWT Trial 3 at Week 12
Hide Description Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Time Frame Change from baseline for sleep latency in MWT during trial 3 at week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.
Arm/Group Title Placebo 75 mg of JZP-110 150 mg JZP-110 300 mg of JZP-110
Hide Arm/Group Description:
Placebo administered orally, QD, for the 12 week treatment phase.
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase and then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase, and received 300 mg JZP-110 starting on Day 4, administered orally, QD.
Overall Number of Participants Analyzed 58 59 55 59
Least Squares Mean (Standard Error)
Unit of Measure: minutes
3.79  (1.799) 6.35  (1.908) 11.31  (1.859) 13.99  (1.996)
7.Secondary Outcome
Title Change in Sleep Latency Time on MWT Trial 4 at Week 12
Hide Description Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Time Frame Change from baseline for sleep latency in MWT during trial 4 at week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.
Arm/Group Title Placebo 75 mg of JZP-110 150 mg JZP-110 300 mg of JZP-110
Hide Arm/Group Description:
Placebo administered orally, QD, for the 12 week treatment phase.
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase and then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase, and received 300 mg JZP-110 starting on Day 4, administered orally, QD.
Overall Number of Participants Analyzed 58 59 55 59
Least Squares Mean (Standard Error)
Unit of Measure: minutes
2.33  (1.579) 3.77  (1.663) 9.77  (1.606) 13.50  (1.734)
8.Secondary Outcome
Title Change in Sleep Latency Time on MWT Trial 5 at Week 12
Hide Description Time course of efficacy in MWT: Change in sleep latency (in minutes) on each of the 5 MWT trials at Week 12.
Time Frame Change from baseline for sleep latency in MWT during trial 5 at week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.
Arm/Group Title Placebo 75 mg of JZP-110 150 mg JZP-110 300 mg of JZP-110
Hide Arm/Group Description:
Placebo administered orally, QD, for the 12 week treatment phase.
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase and then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase, and received 300 mg JZP-110 starting on Day 4, administered orally, QD.
Overall Number of Participants Analyzed 58 59 55 59
Least Squares Mean (Standard Error)
Unit of Measure: minutes
3.09  (1.808) 3.92  (1.928) 9.25  (1.888) 12.20  (1.969)
9.Secondary Outcome
Title Change in the Mean Sleep Latency Time as Determined From the First 4 Trials of a 40-Minute MWT From Baseline to Week 4
Hide Description 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.
Time Frame Baseline to Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Five subjects in the Safety Population were excluded from the mITT Population resulting in a total of 231 subjects.
Arm/Group Title Placebo 75 mg of JZP-110 150 mg JZP-110 300 mg of JZP-110
Hide Arm/Group Description:
Placebo administered orally, QD, for the 12 week treatment phase.
75 mg JZP-110 administered orally, QD, for the 12-week treatment phase.
Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase and then received 150 mg JZP-110 starting on Day 4, administered orally, QD.
Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase, and received 300 mg JZP-110 starting on Day 4, administered orally, QD.
Overall Number of Participants Analyzed 58 59 55 59
Least Squares Mean (Standard Error)
Unit of Measure: minutes
2.16  (1.202) 4.67  (1.223) 9.15  (1.246) 13.07  (1.211)
Time Frame Through Week 14
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo 75 mg of JZP-110 150 mg JZP-110 300 mg of JZP-110
Hide Arm/Group Description Placebo administered orally, QD, for the 12 week treatment phase. 75 mg JZP-110 administered orally, QD, for the 12-week treatment phase. Subjects randomized to receive 150 mg JZP-110 initially received 75 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase and then received 150 mg JZP-110 starting on Day 4, administered orally, QD. Subjects randomized to receive 300 mg JZP-110 initially received 150 mg JZP-110 from Day 1 through Day 3 of the Treatment Phase, and received 300 mg JZP-110 starting on Day 4, administered orally, QD.
All-Cause Mortality
Placebo 75 mg of JZP-110 150 mg JZP-110 300 mg of JZP-110
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/59 (0.00%)   0/59 (0.00%)   0/59 (0.00%) 
Hide Serious Adverse Events
Placebo 75 mg of JZP-110 150 mg JZP-110 300 mg of JZP-110
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)   0/59 (0.00%)   1/59 (1.69%)   0/59 (0.00%) 
General disorders         
Non-cardiac chest pain  1  0/59 (0.00%)  0/59 (0.00%)  1/59 (1.69%)  0/59 (0.00%) 
Psychiatric disorders         
Anxiety  1  0/59 (0.00%)  0/59 (0.00%)  1/59 (1.69%)  0/59 (0.00%) 
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo 75 mg of JZP-110 150 mg JZP-110 300 mg of JZP-110
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/59 (28.81%)   19/59 (32.20%)   32/59 (54.24%)   36/59 (61.02%) 
Gastrointestinal disorders         
Nausea  1  1/59 (1.69%)  3/59 (5.08%)  6/59 (10.17%)  6/59 (10.17%) 
Dry mouth  1  2/59 (3.39%)  3/59 (5.08%)  4/59 (6.78%)  6/59 (10.17%) 
Diarrhoea  1  1/59 (1.69%)  2/59 (3.39%)  3/59 (5.08%)  3/59 (5.08%) 
Dyspepsia  1  0/59 (0.00%)  1/59 (1.69%)  2/59 (3.39%)  3/59 (5.08%) 
Constipation  1  1/59 (1.69%)  3/59 (5.08%)  1/59 (1.69%)  0/59 (0.00%) 
General disorders         
Fatigue  1  0/59 (0.00%)  0/59 (0.00%)  2/59 (3.39%)  3/59 (5.08%) 
Infections and infestations         
Nasopharyngitis  1  3/59 (5.08%)  5/59 (8.47%)  8/59 (13.56%)  3/59 (5.08%) 
Upper respiratory tract infection  1  1/59 (1.69%)  1/59 (1.69%)  4/59 (6.78%)  0/59 (0.00%) 
Influenza  1  3/59 (5.08%)  2/59 (3.39%)  1/59 (1.69%)  1/59 (1.69%) 
Investigations         
Weight decreased  1  0/59 (0.00%)  1/59 (1.69%)  1/59 (1.69%)  3/59 (5.08%) 
Heart rate increased  1  0/59 (0.00%)  0/59 (0.00%)  0/59 (0.00%)  4/59 (6.78%) 
Weight increased  1  3/59 (5.08%)  2/59 (3.39%)  0/59 (0.00%)  1/59 (1.69%) 
Metabolism and nutrition disorders         
Decreased appetite  1  1/59 (1.69%)  5/59 (8.47%)  5/59 (8.47%)  9/59 (15.25%) 
Nervous system disorders         
Headache  1  3/59 (5.08%)  6/59 (10.17%)  14/59 (23.73%)  18/59 (30.51%) 
Dizziness  1  2/59 (3.39%)  2/59 (3.39%)  1/59 (1.69%)  3/59 (5.08%) 
Psychiatric disorders         
Anxiety  1  1/59 (1.69%)  1/59 (1.69%)  3/59 (5.08%)  5/59 (8.47%) 
Insomnia  1  0/59 (0.00%)  2/59 (3.39%)  0/59 (0.00%)  3/59 (5.08%) 
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor can review trial results communications prior to public release and can embargo such communications for a period of at least 60 days from the time submitted to sponsor for review. If requested by sponsor, the PI will withhold publication for up to an additional 30 days. Furthermore, the first publication of study results must be a joint publication of all study sites unless a joint manuscript has not been submitted for publication within 12 months of completion of the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director, Disclosure & Transparency
Organization: Jazz Pharmaceuticals
Phone: 215-970-7145
EMail: ClinicalTrialDisclosure@JazzPharma.com
Layout table for additonal information
Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02348593    
Other Study ID Numbers: 14-002
First Submitted: January 15, 2015
First Posted: January 28, 2015
Results First Submitted: April 19, 2019
Results First Posted: July 23, 2019
Last Update Posted: July 23, 2019