A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness

Narcolepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485770
• Other study ID #: ADX-N05 201
• Status: Completed
• Phase: Phase 2
• Start date: December 2011
• Est. completion date: May 2012

Study information

• Verified date: June 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: 33
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 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 two years

• Nicotine dependence that has an affect on sleep

Related Conditions & MeSH terms

• Narcolepsy
• Sleepiness

Intervention

Drug:
• ADX-N05
150 mg once a day for seven days followed by 300 mg once a day for seven days
• Placebo
Placebo to match ADX-N05 once a day for 2 consecutive weeks

Locations

Country	Name	City	State
United States	Neurotrials Research, Inc.	Atlanta	Georgia
United States	Sleep Disorders Center of Georgia	Atlanta	Georgia
United States	Future Search Trials of Neurology	Austin	Texas
United States	The Center for Sleep and Wake Disorders	Chevy Chase	Maryland
United States	SleepMed of South Carolina	Columbia	South Carolina
United States	Sleep Medicine Associates of Texas	Dallas	Texas
United States	SleepMed of Central Georgia	Macon	Georgia
United States	Pulmonary Associates	Phoenix	Arizona
United States	Clinical Research Group of St. Petersburg	Saint Petersburg	Florida
United States	Mercy St. Anne Sleep Disorders Center	Toledo	Ohio

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) Following Two Weeks of Treatment With ADX-N05 vs. Two Weeks of Treatment With Placebo	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.	Baseline up to 2 weeks post-dose.
Secondary	Change From Baseline in Epworth Sleepiness Scale (ESS) Score During Weeks 1 and 3	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 3 post-dose.
Secondary	Change From Baseline in Epworth Sleepiness Scale (ESS) Score During Weeks 2 and 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	Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores During Weeks 1 and 3	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.	Week 1 and Week 3 post-dose.
Secondary	Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores During Weeks 2 and 4	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.	Week 2 and Week 4 post-dose.