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

Narcolepsy Clinical Trial

Official title:

A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multi-center Study of the Safety and Efficacy of ADX-N05 in the Treatment of Excessive Daytime Sleepiness in Subjects With Narcolepsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01681121
• Other study ID #: ADX-N05 202
• Status: Completed
• Phase: Phase 2
• Start date: September 2012
• Est. completion date: August 2013

Study information

• Verified date: May 2021
• Source: Jazz Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Narcolepsy
• Sleepiness

Intervention

Drug:
• ADX-N05
150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks
• Placebo
One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	Baseline up to Week 12/Last Assessment post-dose.
Primary	Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores for ADX-N05 vs. Placebo at Last Assessment	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.	Week 12
Secondary	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	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.	Baseline up to Week 4 post-dose.
Secondary	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	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.	Baseline up to Week 4 post-dose.
Secondary	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	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).	Baseline up to Week 12/Last Assessment post-dose.
Secondary	Change From Baseline in Epworth Sleepiness Scale (ESS) Scores for ADX-N05 vs. Placebo at Week 4	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.	Baseline up to Week 4 post-dose.
Secondary	Change From Baseline in ESS Scores for ADX-N05 vs. Placebo at Last Assessment	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.	Baseline up to Week 12/Last Assessment post-dose.
Secondary	Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores for ADX-N05 vs. Placebo at 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.	Week 4
Secondary	Number of Participants With Improved Patient Global Impression Change (PGI-C) Scores for ADX-N05 vs. Placebo at 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.	Week 4
Secondary	Number of Participants With Improved PGI-C Scores for ADX-N05 vs. Placebo at 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.	Week 12/Last Assessment