- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02806895
Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in OSA
December 21, 2020 updated by: Jazz Pharmaceuticals
A Randomized, Double-Blind, Placebo-Controlled, Crossover On-Road Driving Study Assessing the Effect of JZP-110 on Driving Performance in Subjects With Excessive Sleepiness Due to Obstructive Sleep Apnea
This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of JZP-110 on driving performance in subjects with excessive sleepiness due to obstructive sleep apnea.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229
- Maastricht University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female, age 21 to 65 years inclusive
- Diagnosis of obstructive sleep apnea (OSA) per International Classification of Sleep Disorders (ICSD-3)
- BMI 18 to <40 kg/m2
- Willing and able to provide written informed consent
Exclusion Criteria:
- Female subjects who are pregnant, nursing, or lactating
- Any other clinically relevant medical, behavioral, or psychiatric disorder other than OSA 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 Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) criteria
- History or presence of any 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 and/or safety assessments per the judgment of the investigator
- History of bariatric surgery within the past year or a history of any gastric bypass procedure
- Presence or history of significant cardiovascular disease
- Unable to washout or refrain from taking any over-the-counter (OTC) or prescription medications that could affect sleep-wake function
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Once daily dosing
|
|
Active Comparator: JZP-110
150 mg/day for first 3 days and 300 mg/day for next 4 days
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Standard Deviation of Lateral Position (SDLP) at 2 Hours Post-dose (Approximately at Tmax)
Time Frame: 2 hours post-dose
|
Subjects were instructed to drive with steady lateral position between the delineated boundaries of the slower (right) traffic lane, while maintaining a constant speed of 95 kilometers (km) per hour (hr).
Deviation was measured by the vehicle's speed and lateral distance to the left lane line and was continuously recorded.
Individual improvement was defined as a decrease in SDLP below the negative value of threshold; individual impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns.
|
2 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SDLP at 6 Hours Post-dose
Time Frame: 6 hours post-dose
|
Subjects were instructed to drive with steady lateral position between the delineated boundaries of the slower (right) traffic lane, while maintaining a constant speed of 95 kilometers (km) per hour (hr).
Deviation was measured by the vehicle's speed and lateral distance to the left lane line and was continuously recorded.
Individual improvement was defined as a decrease in SDLP below the negative value of threshold; individual impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns.
|
6 hours post-dose
|
Number of Subjects With Improved or Impaired Driving at a Threshold 1 Centimeter (cm) on JZP-110 Compared to Placebo 2 Hours Post-dose
Time Frame: 2 hours post-dose
|
Individual changes (solriamfetol minus placebo) in driving performance were measured by SDLP at 2 hours postdose.
The Maximum McNemar symmetry analyses was used to detect an asymmetry in the distribution of the change in driving performance at 2 hours postdose.
The test examined the differences in the proportions of impaired drivers and improved drivers following treatment using a generalized single McNemar test statistics were obtained at each threshold (1.0, 1.5, 2.0, 2.5, 3.0, and 3.5 cm), which was the vehicle weaving amount.
Changes in SDLP exceeding 2.4 cm have been evaluated as clinically relevant.
Improvement was defined as a decrease in SDLP comparing JZP-110 and placebo below the threshold and impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns.
|
2 hours post-dose
|
Number of Subjects With Improved or Impaired Driving at a Threshold 1.5 cm on JZP-110 Compared to Placebo 2 Hours Post-dose
Time Frame: 2 hours post-dose
|
Individual changes (solriamfetol minus placebo) in driving performance were measured by SDLP at 2 hours postdose.
The Maximum McNemar symmetry analyses was used to detect an asymmetry in the distribution of the change in driving performance at 2 hours postdose.
The test examined the differences in the proportions of impaired drivers and improved drivers following treatment using a generalized single McNemar test statistics were obtained at each threshold (1.0, 1.5, 2.0, 2.5, 3.0, and 3.5 cm), which was the vehicle weaving amount.
Changes in SDLP exceeding 2.4 cm have been evaluated as clinically relevant.
Improvement was defined as a decrease in SDLP comparing JZP-110 and placebo below the threshold and impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns.
|
2 hours post-dose
|
Number of Subjects With Improved or Impaired Driving at a Threshold 2.0 cm on JZP-110 Compared to Placebo 2 Hours Post-dose
Time Frame: 2 hours post-dose
|
Individual changes (solriamfetol minus placebo) in driving performance were measured by SDLP at 2 hours postdose.
The Maximum McNemar symmetry analyses was used to detect an asymmetry in the distribution of the change in driving performance at 2 hours postdose.
The test examined the differences in the proportions of impaired drivers and improved drivers following treatment using a generalized single McNemar test statistics were obtained at each threshold (1.0, 1.5, 2.0, 2.5, 3.0, and 3.5 cm), which was the vehicle weaving amount.
Changes in SDLP exceeding 2.4 cm have been evaluated as clinically relevant.
Improvement was defined as a decrease in SDLP comparing JZP-110 and placebo below the threshold and impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns.
|
2 hours post-dose
|
Number of Subjects With Improved or Impaired Driving at a Threshold 2.5 cm on JZP-110 Compared to Placebo 2 Hours Post-dose
Time Frame: 2 hours post-dose
|
Individual changes (solriamfetol minus placebo) in driving performance were measured by SDLP at 2 hours postdose.
The Maximum McNemar symmetry analyses was used to detect an asymmetry in the distribution of the change in driving performance at 2 hours postdose.
The test examined the differences in the proportions of impaired drivers and improved drivers following treatment using a generalized single McNemar test statistics were obtained at each threshold (1.0, 1.5, 2.0, 2.5, 3.0, and 3.5 cm), which was the vehicle weaving amount.
Changes in SDLP exceeding 2.4 cm have been evaluated as clinically relevant.
Improvement was defined as a decrease in SDLP comparing JZP-110 and placebo below the threshold and impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns.
|
2 hours post-dose
|
Number of Subjects With Improved or Impaired Driving at a Threshold 3.0 cm on JZP-110 Compared to Placebo 2 Hours Post-dose
Time Frame: 2 hours post-dose
|
Individual changes (solriamfetol minus placebo) in driving performance were measured by SDLP at 2 hours postdose.
The Maximum McNemar symmetry analyses was used to detect an asymmetry in the distribution of the change in driving performance at 2 hours postdose.
The test examined the differences in the proportions of impaired drivers and improved drivers following treatment using a generalized single McNemar test statistics were obtained at each threshold (1.0, 1.5, 2.0, 2.5, 3.0, and 3.5 cm), which was the vehicle weaving amount.
Changes in SDLP exceeding 2.4 cm have been evaluated as clinically relevant.
Improvement was defined as a decrease in SDLP comparing JZP-110 and placebo below the threshold and impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns.
|
2 hours post-dose
|
Number of Subjects With Improved or Impaired Driving at a Threshold 3.5 cm on JZP-110 Compared to Placebo 2 Hours Post-dose
Time Frame: 2 hours post-dose
|
Individual changes (solriamfetol minus placebo) in driving performance were measured by SDLP at 2 hours postdose.
The Maximum McNemar symmetry analyses was used to detect an asymmetry in the distribution of the change in driving performance at 2 hours postdose.
The test examined the differences in the proportions of impaired drivers and improved drivers following treatment using a generalized single McNemar test statistics were obtained at each threshold (1.0, 1.5, 2.0, 2.5, 3.0, and 3.5 cm), which was the vehicle weaving amount.
Changes in SDLP exceeding 2.4 cm have been evaluated as clinically relevant.
Improvement was defined as a decrease in SDLP comparing JZP-110 and placebo below the threshold and impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns.
|
2 hours post-dose
|
Number of Subjects With Improved or Impaired Driving at a Threshold 1.5 cm on JZP-110 Compared to Placebo 6 Hours Post-dose
Time Frame: 6 hours post-dose
|
Individual changes (solriamfetol minus placebo) in driving performance were measured by SDLP at 6 hours postdose.
The Maximum McNemar symmetry analyses was used to detect an asymmetry in the distribution of the change in driving performance at 6 hours postdose.
The test examined the differences in the proportions of impaired drivers and improved drivers following treatment using a generalized single McNemar test statistics were obtained at each threshold (1.0, 1.5, 2.0, 2.5, 3.0, and 3.5 cm), which was the vehicle weaving amount.
Changes in SDLP exceeding 2.4 cm have been evaluated as clinically relevant.
Improvement was defined as a decrease in SDLP comparing JZP-110 and placebo below the threshold and impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns.
|
6 hours post-dose
|
Number of Subjects With Improved or Impaired Driving at a Threshold 2.0 cm on JZP-110 Compared to Placebo 6 Hours Post-dose
Time Frame: 6 hours post-dose
|
Individual changes (solriamfetol minus placebo) in driving performance were measured by SDLP at 6 hours postdose.
The Maximum McNemar symmetry analyses was used to detect an asymmetry in the distribution of the change in driving performance at 6 hours postdose.
The test examined the differences in the proportions of impaired drivers and improved drivers following treatment using a generalized single McNemar test statistics were obtained at each threshold (1.0, 1.5, 2.0, 2.5, 3.0, and 3.5 cm), which was the vehicle weaving amount.
Changes in SDLP exceeding 2.4 cm have been evaluated as clinically relevant.
Improvement was defined as a decrease in SDLP comparing JZP-110 and placebo below the threshold and impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns.
|
6 hours post-dose
|
Number of Subjects With Improved or Impaired Driving at a Threshold 2.5 cm on JZP-110 Compared to Placebo 6 Hours Post-dose
Time Frame: 6 hours post-dose
|
Individual changes (solriamfetol minus placebo) in driving performance were measured by SDLP at 6 hours postdose.
The Maximum McNemar symmetry analyses was used to detect an asymmetry in the distribution of the change in driving performance at 6 hours postdose.
The test examined the differences in the proportions of impaired drivers and improved drivers following treatment using a generalized single McNemar test statistics were obtained at each threshold (1.0, 1.5, 2.0, 2.5, 3.0, and 3.5 cm), which was the vehicle weaving amount.
Changes in SDLP exceeding 2.4 cm have been evaluated as clinically relevant.
Improvement was defined as a decrease in SDLP comparing JZP-110 and placebo below the threshold and impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns.
|
6 hours post-dose
|
Number of Subjects With Improved or Impaired Driving at a Threshold 3.0 cm on JZP-110 Compared to Placebo 6 Hours Post-dose
Time Frame: 6 hours post-dose
|
Individual changes (solriamfetol minus placebo) in driving performance were measured by SDLP at 6 hours postdose.
The Maximum McNemar symmetry analyses was used to detect an asymmetry in the distribution of the change in driving performance at 6 hours postdose.
The test examined the differences in the proportions of impaired drivers and improved drivers following treatment using a generalized single McNemar test statistics were obtained at each threshold (1.0, 1.5, 2.0, 2.5, 3.0, and 3.5 cm), which was the vehicle weaving amount.
Changes in SDLP exceeding 2.4 cm have been evaluated as clinically relevant.
Improvement was defined as a decrease in SDLP comparing JZP-110 and placebo below the threshold and impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns.
|
6 hours post-dose
|
Number of Subjects With Improved or Impaired Driving at a Threshold 3.5 cm on JZP-110 Compared to Placebo 6 Hours Post-dose
Time Frame: 6 hours post-dose
|
Individual changes (solriamfetol minus placebo) in driving performance were measured by SDLP at 6 hours postdose.
The Maximum McNemar symmetry analyses was used to detect an asymmetry in the distribution of the change in driving performance at 6 hours postdose.
The test examined the differences in the proportions of impaired drivers and improved drivers following treatment using a generalized single McNemar test statistics were obtained at each threshold (1.0, 1.5, 2.0, 2.5, 3.0, and 3.5 cm), which was the vehicle weaving amount.
Changes in SDLP exceeding 2.4 cm have been evaluated as clinically relevant.
Improvement was defined as a decrease in SDLP comparing JZP-110 and placebo below the threshold and impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns.
|
6 hours post-dose
|
Standard Deviation of Speed (SDS) at 2 Hours Post-dose
Time Frame: 2 hours post-dose
|
Mean SDS was a common measure of the driver's ability to maintain a constant driving speed.
Variations in driving speed were recorded and analyzed.
|
2 hours post-dose
|
SDS at 6 Hours Post-dose
Time Frame: 6 hours post-dose
|
Mean SDS was a common measure of the driver's ability to maintain a constant driving speed.
Variations in driving speed were recorded and analyzed.
|
6 hours post-dose
|
Toronto Hospital Alert Test (THAT)
Time Frame: Post Treatment at day 21
|
THAT is a 10-item self-report questionnaire designed to measure perceived alertness in the preceding week.
The THAT was administered at baseline and the end of each treatment period.
The total score of THAT can range between 0 to 50 where the higher score indicates greater alertness.
|
Post Treatment at day 21
|
Number of Subjects With Improved or Impaired Driving at a Threshold 1.0 cm on JZP-110 Compared to Placebo 6 Hours Post-dose
Time Frame: 6 hours post-dose
|
Individual changes (solriamfetol minus placebo) in driving performance were measured by SDLP at 6 hours postdose.
The Maximum McNemar symmetry analyses was used to detect an asymmetry in the distribution of the change in driving performance at 6 hours postdose.
The test examined the differences in the proportions of impaired drivers and improved drivers following treatment using a generalized single McNemar test statistics were obtained at each threshold (1.0, 1.5, 2.0, 2.5, 3.0, and 3.5 cm), which was the vehicle weaving amount.
Changes in SDLP exceeding 2.4 cm have been evaluated as clinically relevant.
Improvement was defined as a decrease in SDLP comparing JZP-110 and placebo below the threshold and impairment was defined as an increase in SDLP above the threshold or failure to complete the driving test due to sleepiness or subjects related safety concerns.
|
6 hours post-dose
|
Number of Lapses in Driving Test at 2 Hours Post-dose
Time Frame: 2 hours post-dose
|
Driving lapses (also known as lane drift, defined as deviations > 100 cm from the mean lateral position and from the absolute lateral position for 8 seconds.
Driving performance will be assessed using a standardized on-road driving test on Day 7 (Visit 4) and on Day 14 (Visit 5).
A practice driving test will be done during the screening period to familiarize the subject with the vehicle and test scenario, assess if the subject can adequately operate the manual transmission vehicle, and determine if any safety concerns exist that exclude the subject from participating in the study.
|
2 hours post-dose
|
Number of Lapses in Driving Test at 6 Hours Post-dose
Time Frame: 6 hours post-dose
|
Driving lapses (also known as lane drift, defined as deviations > 100 cm from the mean lateral position and from the absolute lateral position for 8 seconds.
Driving performance will be assessed using a standardized on-road driving test on Day 7 (Visit 4) and on Day 14 (Visit 5).
A practice driving test will be done during the screening period to familiarize the subject with the vehicle and test scenario, assess if the subject can adequately operate the manual transmission vehicle, and determine if any safety concerns exist that exclude the subject from participating in the study.
|
6 hours post-dose
|
Psychomotor Vigilance Test (PVT) Number of Lapses at 2 Hours Post-dose
Time Frame: 2 hours post-dose
|
The PVT was administered at screening for practice only, and at pre-dose and within 30 minutes before each driving test on Days 7 and 14 (Visits 4 and 5, respectively).
The test was administered over 10 minutes with visual stimuli appearing randomly at variable intervals of 2 to 10 seconds.
Subjects were instructed to respond to the appearance of a visual stimulus on a computer screen by pushing a response button as quickly as possible.
Lapses were measured as (RT > 500 msec).
|
2 hours post-dose
|
PVT Number of Lapses at 6 Hours Post-dose
Time Frame: 6 hours post-dose
|
The PVT was administered at screening for practice only, and at pre-dose and within 30 minutes before each driving test on Days 7 and 14 (Visits 4 and 5, respectively).
The test was administered over 10 minutes with visual stimuli appearing randomly at variable intervals of 2 to 10 seconds.
Subjects were instructed to respond to the appearance of a visual stimulus on a computer screen by pushing a response button as quickly as possible.
Lapses were measured as (RT > 500 msec).
|
6 hours post-dose
|
PVT Mean Reaction Time at 2 Hours Post-dose
Time Frame: 2 hours post-dose
|
The PVT was administered at screening for practice only, and at pre-dose and within 30 minutes before each driving test on Days 7 and 14 (Visits 4 and 5, respectively).
The test was administered over 10 minutes with visual stimuli appearing randomly at variable intervals of 2 to 10 seconds.
Subjects were instructed to respond to the appearance of a visual stimulus on a computer screen by pushing a response button as quickly as possible.
Mean RT is measured in msec.
|
2 hours post-dose
|
PVT Mean Reaction Time at 6 Hours Post-dose
Time Frame: 6 hours post-dose
|
The PVT was administered at screening for practice only, and at pre-dose and within 30 minutes before each driving test on Days 7 and 14 (Visits 4 and 5, respectively).
The test was administered over 10 minutes with visual stimuli appearing randomly at variable intervals of 2 to 10 seconds.
Subjects were instructed to respond to the appearance of a visual stimulus on a computer screen by pushing a response button as quickly as possible.
Mean RT is measured In msec.
|
6 hours post-dose
|
PVT Inverse Reaction Time at 2 Hours Post-dose
Time Frame: 2 hours post-dose
|
The PVT was administered at screening for practice only, and at pre-dose and within 30 minutes before each driving test on Days 7 and 14 (Visits 4 and 5, respectively).
The test was administered over 10 minutes with visual stimuli appearing randomly at variable intervals of 2 to 10 seconds.
Subjects were instructed to respond to the appearance of a visual stimulus on a computer screen by pushing a response button as quickly as possible.
Inverse reaction time was expressed as 1/reaction time in msec.
|
2 hours post-dose
|
PVT Inverse Reaction Time at 6 Hours Post-dose
Time Frame: 6 hours post-dose
|
The PVT was administered at screening for practice only, and at pre-dose and within 30 minutes before each driving test on Days 7 and 14 (Visits 4 and 5, respectively).
The test was administered over 10 minutes with visual stimuli appearing randomly at variable intervals of 2 to 10 seconds.
Subjects were instructed to respond to the appearance of a visual stimulus on a computer screen by pushing a response button as quickly as possible.
Inverse reaction time was expressed as 1/reaction time in msec.
|
6 hours post-dose
|
PVT Number of Errors of Commission at 2 Hours Post-dose
Time Frame: 2 hours post-dose
|
The PVT was administered at screening for practice only, and at pre-dose and within 30 minutes before each driving test on Days 7 and 14 (Visits 4 and 5, respectively).
The test was administered over 10 minutes with visual stimuli appearing randomly at variable intervals of 2 to 10 seconds.
Subjects were instructed to respond to the appearance of a visual stimulus on a computer screen by pushing a response button as quickly as possible.
Errors of commission were measured as the number of responses without a stimulus or false starts with (RT < 100 msec).
|
2 hours post-dose
|
PVT Number of Errors of Commission at 6 Hours Post-dose
Time Frame: 6 hours post-dose
|
The PVT was administered at screening for practice only, and at pre-dose and within 30 minutes before each driving test on Days 7 and 14 (Visits 4 and 5, respectively).
The test was administered over 10 minutes with visual stimuli appearing randomly at variable intervals of 2 to 10 seconds.
Subjects were instructed to respond to the appearance of a visual stimulus on a computer screen by pushing a response button as quickly as possible.
Errors of commission were measured as the number of responses without a stimulus or false starts with (RT < 100 msec).
|
6 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jan Ramaekers, PhD, Maastricht University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 5, 2016
Primary Completion (Actual)
May 28, 2019
Study Completion (Actual)
May 28, 2019
Study Registration Dates
First Submitted
June 10, 2016
First Submitted That Met QC Criteria
June 16, 2016
First Posted (Estimate)
June 21, 2016
Study Record Updates
Last Update Posted (Actual)
January 14, 2021
Last Update Submitted That Met QC Criteria
December 21, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-004
- 2015-003930-28 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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