A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
← catalyst calendarNCT07455383 · readout ≤ 285 d
Sponsored by Alkermes, Inc. (industry) · ALKS — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
150estimated
Sites
29
Countries
Australia, Belgium, Canada +3
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-04-06 | actual | When the study began enrolling |
| Primary completion | May 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2026-03-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-07 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Narcolepsy Type 1
Interventions
- Drug: ALKS 2680 Dose 1 — also filed as Alixorexton
- Drug: ALKS 2680 Dose 2 — also filed as Alixorexton
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFChange in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose level
measured Baseline to Week 12
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