The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
92
Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6
Time frame: Baseline to Week 6
Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6
Epsworth Sleepiness Scale is a 4-point scale used to measure excessive sleepiness from 0 (would never doze) to 3 (high chance of "dozing)
Time frame: Baseline to Week 6
Mean weekly cataplexy rate (WCR) as derived by subject cataplexy diary
Time frame: Measured at Week 5 and 6
Incidence of adverse events
Time frame: Up to 15 Weeks
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