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"Six-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA" (OSA)

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ClinicalTrials.gov Identifier: NCT02348619
Recruitment Status : Completed
First Posted : January 28, 2015
Results First Posted : September 9, 2019
Last Update Posted : September 9, 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 Obstructive Sleep Apnea
Intervention Drug: JZP-110
Enrollment 174
Recruitment Details  
Pre-assignment Details Following screening, subjects entered the Titration phase. Subjects who were titrated to an efficacious and tolerable dose in the Titration phase remained on the same dose regimen in the Stable-Dose phase. Subjects in the Double-Blind Withdrawal phase who did not receive JZP-110 received placebo for 2 weeks.
Arm/Group Title JZP-110 Placebo
Hide Arm/Group Description Start at 75 mg, titrate up to 150 or 300 mg, or down at any time. Subjects in the Double-Blind Withdrawal phase who did not receive JZP-110 received placebo for 2 weeks.
Period Title: Titration Phase
Started 174 0
Completed 157 0
Not Completed 17 0
Period Title: Stable-Dose Phase
Started 157 0
Completed 124 0
Not Completed 33 0
Period Title: Double-Blind Withdrawal Phase
Started 62 62
Completed 60 62
Not Completed 2 0
Arm/Group Title Double-Blind Withdrawal Phase
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 124
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Placebo Number Analyzed 124 participants
56.2  (9.75)
JZP-110 Number Analyzed 124 participants
56.3  (11.36)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Placebo Number Analyzed 62 participants
Female
21
  33.9%
Male
41
  66.1%
JZP-110 Number Analyzed 62 participants
Female
26
  41.9%
Male
36
  58.1%
[1]
Measure Analysis Population Description: A total of 124 subjects were randomized into the Double-Blind Withdrawal phase of the study and comprised the Safety population for that phase. Two of these subjects were excluded.
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Placebo Number Analyzed 62 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   3.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
15
  24.2%
White
45
  72.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
JZP-110 Number Analyzed 62 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
12
  19.4%
White
50
  80.6%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
[1]
Measure Analysis Population Description: A total of 124 subjects were randomized into the Double-Blind Withdrawal phase of the study and comprised the Safety population for that phase. Two of these subjects were excluded.
1.Primary Outcome
Title Change in the Maintenance of Wakefulness Test (MWT)
Hide Description Change in the mean sleep latency time as determined from the first four trials of a 40-minute MWT from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. Mean sleep latency defined as the average of the first four MWT trial's measurements.
Time Frame Week 4 to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title JZP-110 Placebo
Hide Arm/Group Description:
Start at 75 mg, titrate up to 150 or 300 mg, or down at any time.
Subjects in the Double-Blind Withdrawal phase who did not receive JZP-110 received placebo for 2 weeks.
Overall Number of Participants Analyzed 60 62
Least Squares Mean (Standard Error)
Unit of Measure: minutes
-0.96  (1.350) -12.11  (1.326)
2.Primary Outcome
Title Change in the Epworth Sleepiness Scale (ESS)
Hide Description

Change in Epworth Sleepiness Scale (ESS) score from the end of the Stable Dose Phase to the end of the Double-blind Withdrawal Phase. 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 week 4 to week 6.

Time Frame Week 4 to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title JZP-110 Placebo
Hide Arm/Group Description:
Start at 75 mg, titrate up to 150 or 300 mg, or down at any time.
Subjects in the Double-Blind Withdrawal phase who did not receive JZP-110 received placebo for 2 weeks.
Overall Number of Participants Analyzed 60 62
Least Squares Mean (Standard Error)
Unit of Measure: points on a scale
-0.1  (0.73) 4.5  (0.71)
3.Secondary Outcome
Title Patient Global Impression of Change (PGIc)
Hide Description Percentage of subjects reported as worse (minimally, much, or very much) on the PGIc at the end of the Double-blind Withdrawal Phase. 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 Week 4 to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title JZP-110 Placebo
Hide Arm/Group Description:
Start at 75 mg, titrate up to 150 or 300 mg, or down at any time.
Subjects in the Double-Blind Withdrawal phase who did not receive JZP-110 received placebo for 2 weeks.
Overall Number of Participants Analyzed 60 62
Measure Type: Number
Unit of Measure: percentage of subjects
20 50
4.Secondary Outcome
Title Clinical Global Impression of Change (CGIc)
Hide Description Percentage of subjects reported as worse (minimally, much, or very much) on the CGIc at the end of the Double-blind Withdrawal Phase. CGIc was rated by clinicians and measures the change in the subject's condition since treatment starts on a 7-point scale ranging from 1= very much improved to 7= very much worse.
Time Frame Week 4 to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title JZP-110 Placebo
Hide Arm/Group Description:
Start at 75 mg, titrate up to 150 or 300 mg, or down at any time.
Subjects in the Double-Blind Withdrawal phase who did not receive JZP-110 received placebo for 2 weeks.
Overall Number of Participants Analyzed 60 62
Measure Type: Number
Unit of Measure: percentage of subjects
22 59
5.Secondary Outcome
Title Change in Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Hide Description Change is total score from the end of the stable dose phase to the end of the double blind withdrawal phase. Functional Outcomes of Sleep Questionnaire Short Version (FOSQ-10) is a 10-item disease-specific quality of life questionnaire to assess the effect of excessiveness sleepiness on multiple activities of everyday living. The FOSQ-10 consists of 10 questions, each scored on a scale from 1-4. The questionnaire has a 4-point response format for each question (1 = extreme difficulty, 2 = moderate difficulty, 3 = a little difficulty, and 4 = no difficulty). The total score is derived by the mean of the 5 subscale scores, multiplied by 5, resulting in a possible range of scores between 5 to 20; lower FOSQ-10 scores are worse, indicating more difficulty carrying out activities; higher FOSQ-10 scores are better, indicating less difficulty carrying out activities.
Time Frame Week 4 to Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title JZP-110 Placebo
Hide Arm/Group Description:
Start at 75 mg, titrate up to 150 or 300 mg, or down at any time.
Subjects in the Double-Blind Withdrawal phase who did not receive JZP-110 received placebo for 2 weeks.
Overall Number of Participants Analyzed 60 62
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.15  (0.393) -1.31  (0.381)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title JZP-110 (Entire Study) Placebo (Randomized Withdrawal)
Hide Arm/Group Description Across the entire study. During the randomized withdrawal phase only.
All-Cause Mortality
JZP-110 (Entire Study) Placebo (Randomized Withdrawal)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/174 (0.00%)   0/62 (0.00%) 
Hide Serious Adverse Events
JZP-110 (Entire Study) Placebo (Randomized Withdrawal)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/174 (0.00%)   0/62 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
JZP-110 (Entire Study) Placebo (Randomized Withdrawal)
Affected / at Risk (%) Affected / at Risk (%)
Total   58/174 (33.33%)   0/62 (0.00%) 
Cardiac disorders     
Palpitations  9/174 (5.17%)  0/62 (0.00%) 
Gastrointestinal disorders     
Dry mouth  13/174 (7.47%)  0/62 (0.00%) 
Nausea  13/174 (7.47%)  0/62 (0.00%) 
Nervous system disorders     
Headache  20/174 (11.49%)  0/62 (0.00%) 
Dizziness  14/174 (8.05%)  0/62 (0.00%) 
Psychiatric disorders     
Insomnia  11/174 (6.32%)  0/62 (0.00%) 
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: 2158709177
EMail: ClinicalTrialDisclosure@JazzPharma.com
Layout table for additonal information
Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02348619    
Other Study ID Numbers: 14-004
First Submitted: January 15, 2015
First Posted: January 28, 2015
Results First Submitted: April 19, 2019
Results First Posted: September 9, 2019
Last Update Posted: September 9, 2019