A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523911-13-00

Enrollment

Registered

2026-06-02

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Narcolepsy Type 1

Brief summary

Change in Epworth Sleepiness Scale from baseline to Week 12 by dose level

Detailed description

Change in mean sleep latency on Maintenance of Wakefulness Test from baseline to Week 12 by dose level, Weekly cataplexy rate (WCR) at Week 12 by dose level, Change in select patient-reported outcome measures from baseline to Week 12 by dose level

Interventions

DRUGPlacebo to match ALKS 2680

DRUGPlacebo to match Alks 2680/Alixorexton

DRUGALKS 2680

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in Epworth Sleepiness Scale from baseline to Week 12 by dose level	—

Secondary

Measure	Time frame
Change in mean sleep latency on Maintenance of Wakefulness Test from baseline to Week 12 by dose level, Weekly cataplexy rate (WCR) at Week 12 by dose level, Change in select patient-reported outcome measures from baseline to Week 12 by dose level	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 4, 2026