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

Phase 2

Completed

• Conditions: Narcolepsy
• Interventions: Drug: ADX-N05; Drug: Placebo

• Registration Number: NCT01485770
• 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

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-02
• Study First Submitted QC: 2011-12-02
• Study First Posted: 2011-12-06
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Disposition First Submitted: 2013-03-08
• Disposition First Submitted QC: 2013-03-08
• Disposition First Posted: 2013-03-18
• Results First Submitted: 2021-04-28
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-11
• Last Update Submitted: 2021-06-11
• Results First Posted: 2021-07-06
• Last Update Posted: 2021-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ADX-N05, Then Placebo	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).
Placebo, Then ADX-N05	Placebo	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).
Placebo, Then ADX-N05	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).
ADX-N05, Then Placebo	ADX-N05	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).

Primary Outcome Measures

Name	Time	Method
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	Baseline up to 2 weeks post-dose.	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Epworth Sleepiness Scale (ESS) Score During Weeks 1 and 3	Baseline up to Week 3 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 Epworth Sleepiness Scale (ESS) Score During Weeks 2 and 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.
Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores During Weeks 1 and 3	Week 1 and Week 3 post-dose.	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.
Number of Participants With Improved Clinical Global Impression of Change (CGI-C) Scores During Weeks 2 and 4	Week 2 and Week 4 post-dose.	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.

Trial Locations

Locations (10)

SleepMed of South Carolina; 🇺🇸 Columbia, South Carolina, United States

The Center for Sleep and Wake Disorders; 🇺🇸 Chevy Chase, Maryland, United States

Future Search Trials of Neurology; 🇺🇸 Austin, Texas, United States

Neurotrials Research, Inc.; 🇺🇸 Atlanta, Georgia, United States

Mercy St. Anne Sleep Disorders Center; 🇺🇸 Toledo, Ohio, United States

Sleep Disorders Center of Georgia; 🇺🇸 Atlanta, Georgia, United States

Sleep Medicine Associates of Texas; 🇺🇸 Dallas, Texas, United States

Clinical Research Group of St. Petersburg; 🇺🇸 Saint Petersburg, Florida, United States

SleepMed of Central Georgia; 🇺🇸 Macon, Georgia, United States

Pulmonary Associates; 🇺🇸 Phoenix, Arizona, United States