The purpose of this study is to measure decreases in daytime sleepiness, and disease symptoms in participants with Narcolepsy Type 2 (NT2) when taking ALKS 2680 tablets compared with placebo tablets.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
176
Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose level
Time frame: Baseline to Week 12
Change in Epworth Sleepiness Scale (ESS) from baseline to Week 12 by dose level
Time frame: Baseline to Week 12
Percentage of participants who achieve a status of "none" or "mild" on Patient Global Impression-Severity (PGI-S) scale (general disease) at Week 12 by dose level
Time frame: Week 12
Change in British Columbia Cognitive Complaints Inventory (BC-CCI) from baseline to Week 12 by dose level
Time frame: Baseline to Week 12
Change in number of lapses on Psychomotor Vigilance Task (PVT) from baseline to Week 12 by dose level
Time frame: Baseline to Week 12
Change in Patient-Reported Outcomes Measurement Information System - Fatigue 6a (PROMIS Fatigue 6a) from baseline to Week 12 by dose level
Time frame: Baseline to Week 12
Percentage of participants who achieve a status of "normal, not ill at all", "borderline ill", or "mildly ill" on Clinical Global Impression-Severity (CGI-S) (general disease) at Week 12 by dose level
Time frame: Week 12
Incidence of treatment emergent adverse events
Time frame: Up to 14 weeks
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Participants will receive placebo tablets, daily, orally for 12 weeks