- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01485770
A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
June 11, 2021 updated by: Jazz Pharmaceuticals
A Four-week, Double-blind, Placebo-controlled, Randomized, Cross-over Study of the Safety and Efficacy of ADX-N05 in the Treatment of Excessive Daytime Sleepiness
This is a study to evaluate the safety and effectiveness of ADX-N05 compared to placebo in the treatment of excessive daytime sleepiness in adults with narcolepsy.
Study Overview
Study Type
Interventional
Enrollment (Actual)
33
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
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Arizona
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Phoenix, Arizona, United States, 85006
- Pulmonary Associates
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Florida
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Saint Petersburg, Florida, United States, 33707
- Clinical Research Group of St. Petersburg
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Georgia
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Atlanta, Georgia, United States, 30342
- Sleep Disorders Center of Georgia
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Atlanta, Georgia, United States, 30342
- NeuroTrials Research, Inc.
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Macon, Georgia, United States, 31201
- SleepMed of Central Georgia
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Maryland
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Chevy Chase, Maryland, United States, 20815
- The Center for Sleep and Wake Disorders
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Ohio
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Toledo, Ohio, United States, 43623
- Mercy St. Anne Sleep Disorders Center
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South Carolina
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Columbia, South Carolina, United States, 29201
- SleepMed of South Carolina
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Texas
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Austin, Texas, United States, 78731
- Future Search Trials of Neurology
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Dallas, Texas, United States, 75231
- Sleep Medicine Associates of Texas
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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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of narcolepsy
- Good general health
- Willing and able to comply with the study design and schedule and other requirements
Exclusion Criteria:
- If female, pregnant or lactating
- Customary bedtime later than midnight
- History of significant medical condition, behavioral or psychiatric disorder (including suicidal ideation), or surgical history
- Any other clinically relevant medical, behavioral or psychiatric disorder other than narcolepsy that is associated with excessive sleepiness
- History of significant cardiovascular disease
- Body mass index >34
- Excessive caffeine use - > 600 mg/day of caffeine or > 6 cups of coffee/day
- History of alcohol or drug abuse within the past two years
- Nicotine dependence that has an affect on sleep
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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Placebo, Then ADX-N05
Participants first receive a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 1 and 2).
They will then receive ADX-N05 150 mg tablet once a day for seven days (Week 3) followed by 300 mg (2 tablets) once a day for seven days (Week 4).
|
150 mg once a day for seven days followed by 300 mg once a day for seven days
Placebo to match ADX-N05 once a day for 2 consecutive weeks
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Placebo Comparator: ADX-N05, Then Placebo
Participants first receive ADX-N05 150 mg tablet once a day for seven days (Week 1) followed by 300 mg (2 tablets) once a day for seven days (Week 2).
They will then receive a placebo to match ADX-N05 once a day for 2 consecutive weeks (Weeks 3 and 4).
|
150 mg once a day for seven days followed by 300 mg once a day for seven days
Placebo to match ADX-N05 once a day for 2 consecutive weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) Following Two Weeks of Treatment With ADX-N05 vs. Two Weeks of Treatment With Placebo
Time Frame: Baseline up to 2 weeks post-dose.
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The MWT is a validated objective measure of the ability to stay awake for a defined period of time.
The change from baseline in the mean sleep latency from the MWT was the average of sleep latency from the four trials of the MWT.
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Baseline up to 2 weeks post-dose.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Epworth Sleepiness Scale (ESS) Score During Weeks 1 and 3
Time Frame: Baseline up to Week 3 post-dose.
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The ESS is a questionnaire intended to measure daytime sleepiness.
In this test, participants answer questions with regard to the level of sleepiness they experienced over approximately the 7 days prior to the assessment while performing eight common, non-stimulating activities.
The ESS total score range is 1 to 24.
Each activity is rated on a 4-point scale ranging from a minimum of "would never doze" to a maximum of "a high chance of dozing."
Thus, the ESS scale range is as follows: 0=would never doze, 1=slight chance of dozing, 2=moderate chance of dozing, 3=high chance of dozing; 0 indicates a better outcome, and 3 indicates a worse outcome.
A negative mean change value indicates a decrease in score from baseline and an improvement in daytime sleepiness.
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Baseline up to Week 3 post-dose.
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Change From Baseline in Epworth Sleepiness Scale (ESS) Score During Weeks 2 and 4
Time Frame: Baseline up to Week 4 post-dose.
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The ESS is a questionnaire intended to measure daytime sleepiness.
In this test, participants answer questions with regard to the level of sleepiness they experienced over approximately the 7 days prior to the assessment while performing eight common, non-stimulating activities.
The ESS total score range is 1 to 24.
Each activity is rated on a 4-point scale ranging from a minimum of "would never doze" to a maximum of "a high chance of dozing."
Thus, the ESS scale range is as follows: 0=would never doze, 1=slight chance of dozing, 2=moderate chance of dozing, 3=high chance of dozing; 0 indicates a better outcome, and 3 indicates a worse outcome.
A negative mean change value indicates a decrease in score from baseline and an improvement in daytime sleepiness.
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Baseline up to Week 4 post-dose.
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Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores During Weeks 1 and 3
Time Frame: Week 1 and Week 3 post-dose.
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The CGI-C scale was completed at Week 1 through 4 visits.
The participant was rated on a 7-point scale ranging from a minimum of "Very much improved" to a maximum of "Very much worse."
The proportion of participants experiencing at least minimal improvement on the CGI-C was calculated and summarized for each of the two weeks of each of the treatment periods.
The CGI-C scale consists of the following ratings: 1-Very Much improved, 2-Much improved, 3-Minimally improved, 4-No change, 5-Minimally worse, 6-Much worse, 7-Very much worse; a rating of 1 indicates a better outcome, and a rating of 7 indicates a worse outcome.
Improvement was defined as a CGI-rating of 1, 2, or 3.
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Week 1 and Week 3 post-dose.
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Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores During Weeks 2 and 4
Time Frame: Week 2 and Week 4 post-dose.
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The CGI-C scale was completed at Week 1 through 4 visits.
The participant was rated on a 7-point scale ranging from a minimum of "Very much improved" to a maximum of "Very much worse."
The proportion of participants experiencing at least minimal improvement on the CGI-C was calculated and summarized for each of the two weeks of each of the treatment periods.
The CGI-C scale consists of the following ratings: 1-Very Much improved, 2-Much improved, 3-Minimally improved, 4-No change, 5-Minimally worse, 6-Much worse, 7-Very much worse; a rating of 1 indicates a better outcome, and a rating of 7 indicates a worse outcome.
Improvement was defined as a CGI-rating of 1, 2, or 3.
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Week 2 and Week 4 post-dose.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
December 1, 2011
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
December 2, 2011
First Submitted That Met QC Criteria
December 2, 2011
First Posted (Estimate)
December 6, 2011
Study Record Updates
Last Update Posted (Actual)
July 6, 2021
Last Update Submitted That Met QC Criteria
June 11, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADX-N05 201
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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