A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy

Phase 2

Completed

Conditions: Narcolepsy

Interventions: Drug: ADX-N05
Drug: Placebo

Registration Number: NCT01681121

Lead Sponsor: Jazz Pharmaceuticals

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 93

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 2 years
Nicotine dependence that has an effect on sleep

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADX-N05	ADX-N05	ADX-N05 to be taken once a day for 12 weeks
Placebo	Placebo	Placebo to match ADX-N05 to be taken once a day for 12 weeks

Primary Outcome Measures

Name	Time	Method
Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores for ADX-N05 vs. Placebo at Last Assessment	Week 12	The CGI-C scale rated the change in the participant's condition as compared to the Baseline visit on a 7-point scale ranging from a minimum of "Very much improved" to a maximum of "Very much worse." The proportion of subjects experiencing at least minimal improvement on the CGI-C was calculated and summarized for each of the treatment groups at Week 4 and the last available post-Baseline assessment (Week 12/Last Assessment). 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.
Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) for ADX-N05 300 mg vs. Placebo at Last Assessment.	Baseline up to Week 12/Last Assessment post-dose.	The MWT is a validated objective measure of the ability to stay awake for a defined period of time. The primary analysis was a comparison of treatments vs. control groups on change from Baseline to last available post-Baseline assessment (Week 12/Last Assessment) in the average sleep latency time (in minutes) averaged across the first four trials of the MWT using a two-sample t-test.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Improved PGI-C Scores for ADX-N05 vs. Placebo at Last Assessment	Week 12/Last Assessment	The Patient Global Impression - Change (PGI-C) scale was completed by the subject at the Weeks 1, 2, 4, 6, 8, and 12 visits. The CGI-C scale rated the change in the participant's condition as compared to the Baseline visit on a 7-point scale ranging from a minimum of "Very much improved" to a maximum of "Very much worse." The proportion of subjects experiencing at least minimal improvement on the CGI-C was calculated and summarized for each of the treatment groups at Week 4 and the last available post-Baseline assessment (Week 12/Last Assessment). 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.
Change From Baseline in Sleep Latency Time (in Minutes) as Determined From Each of the 5 Individual MWT Trials for ADX-N05 vs. Placebo at Last Assessment	Baseline up to Week 12/Last Assessment post-dose.	The MWT is a validated objective measure of the ability to stay awake for a defined period of time. The MWT consisted of five 40-minute trials separated by 2 hour intervals. This secondary analysis repeated the primary analysis for effects for the five MWT trials analyzed separately at the last available post-Baseline assessment (Week 12/Last Assessment).
Change From Baseline in Epworth Sleepiness Scale (ESS) Scores for ADX-N05 vs. Placebo at Week 4	Baseline up to Week 4 post-dose.	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.
Change From Baseline in ESS Scores for ADX-N05 vs. Placebo at Last Assessment	Baseline up to Week 12/Last Assessment post-dose.	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.
Change From Baseline in the Average Sleep Latency Time (in Minutes) as Determined From the Maintenance of Wakefulness Test (MWT) (Average of the First Four Trials) Following Four Weeks of Treatment With ADX-N05 150 mg vs. Placebo	Baseline up to Week 4 post-dose.	The MWT is a validated objective measure of the ability to stay awake for a defined period of time. The MWT consisted of five 40-minute trials separated by 2 hour intervals. This secondary analysis repeated the primary analysis for effects at the end of Week 4.
Change From Baseline in Sleep Latency Time (in Minutes) as Determined From Each of the 5 Individual MWT Trials for ADX-N05 vs. Placebo at Week 4	Baseline up to Week 4 post-dose.	The MWT is a validated objective measure of the ability to stay awake for a defined period of time. The MWT consisted of five 40-minute trials separated by 2 hour intervals. This secondary analysis repeated the primary analysis for effects for the five MWT trials analyzed separately at Week 4.
Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores for ADX-N05 vs. Placebo at Week 4	Week 4	The CGI-C scale rated the change in the participant's condition as compared to the Baseline visit on a 7-point scale ranging from a minimum of "Very much improved" to a maximum of "Very much worse." The proportion of subjects experiencing at least minimal improvement on the CGI-C was calculated and summarized for each of the treatment groups at Week 4 and the last available post-Baseline assessment (Week 12/Last Assessment). 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.
Number of Participants With Improved Patient Global Impression Change (PGI-C) Scores for ADX-N05 vs. Placebo at Week 4	Week 4	The Patient Global Impression - Change (PGI-C) scale was completed by the subject at the Weeks 1, 2, 4, 6, 8, and 12 visits. The CGI-C scale rated the change in the participant's condition as compared to the Baseline visit on a 7-point scale ranging from a minimum of "Very much improved" to a maximum of "Very much worse." The proportion of subjects experiencing at least minimal improvement on the CGI-C was calculated and summarized for each of the treatment groups at Week 4 and the last available post-Baseline assessment (Week 12/Last Assessment). 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.

Trial Locations

Locations (28): The Center for Sleep and Wake Disorders
🇺🇸
Chevy Chase, Maryland, United States
Chicago Research Center
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Chicago, Illinois, United States
Washington University
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Saint Louis, Missouri, United States
Community Research
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Crestview Hills, Kentucky, United States
Future Search Trials of Neurology
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Austin, Texas, United States
Pulmonary and Critical Care Associates of Baltimore
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Towson, Maryland, United States
SleepMed of Central Georgia
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Macon, Georgia, United States
Sleep Disorders Center of Georgia
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Atlanta, Georgia, United States
Kentucky Research Group
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Louisville, Kentucky, United States
Todd J. Swick, MD, PA
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Houston, Texas, United States
Sleep Disorders Center of Alabama
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Birmingham, Alabama, United States
Pulmonary Associates
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Phoenix, Arizona, United States
Sleep-Alertness Disorders Center
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Aurora, Colorado, United States
Neurocare, Inc.
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Newton, Massachusetts, United States
Pacific Research Network
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San Diego, California, United States
Stanford Sleep Medicine Center
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Redwood City, California, United States
Clinical Research Group of St. Petersburg
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Saint Petersburg, Florida, United States
NeuroTrials Research, Inc.
🇺🇸
Atlanta, Georgia, United States
PAB Clinical Research
🇺🇸
Brandon, Florida, United States
Minnesota Lung Center and Sleep Institute
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Edina, Minnesota, United States
Rex Sleep Disorders Center
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Raleigh, North Carolina, United States
Mercy St. Vincent Medical Center
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Toledo, Ohio, United States
Center for Sleep Medicine
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Philadelphia, Pennsylvania, United States
Wake Research Associates
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Raleigh, North Carolina, United States
SleepMed of South Carolina
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Columbia, South Carolina, United States
Sleep Medicine Associates of Texas
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Dallas, Texas, United States
Metroplex Pulmonary and Sleep Center
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McKinney, Texas, United States
Sleep Therapy and Research Center
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San Antonio, Texas, United States