NCT01485770 - A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

33

Conditions

Narcolepsy

Interventions

ADX-N05DRUG

150 mg once a day for seven days followed by 300 mg once a day for seven days

PlaceboDRUG

Placebo to match ADX-N05 once a day for 2 consecutive weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (10)

Pulmonary Associates

Phoenix, Arizona, United States

Clinical Research Group of St. Petersburg

St. Petersburg, Florida, United States

Neurotrials Research, Inc.

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline up to 2 weeks post-dose.

Secondary Outcomes

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.

Time frame: 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.