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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Narcolepsy

Intervention / Treatment
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* Drug: ADX-N05
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo, Then ADX-N05<br>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). | Drug: ADX-N05<br>* 150 mg once a day for seven days followed by 300 mg once a day for seven days<br>Drug: Placebo<br>* Placebo to match ADX-N05 once a day for 2 consecutive weeks<br>|
| Placebo Comparator: ADX-N05, Then Placebo<br>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). | Drug: ADX-N05<br>* 150 mg once a day for seven days followed by 300 mg once a day for seven days<br>Drug: Placebo<br>* Placebo to match ADX-N05 once a day for 2 consecutive weeks<br>|

What is the study measuring?
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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 | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. |