A Phase 2, Parallel-Group, Dose-Range-Finding Study With Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Narcolepsy Type 1

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511112-24-00

Acronym

ALKS 2680-201

Enrollment

117

Registered

2024-08-16

Start date

2025-01-17

Completion date

2025-07-31

Last updated

2025-07-08

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 the MSL on MWT from baseline to Week 6 by dose level

Detailed description

Change in ESS from baseline to Week 6 by dose level, Mean WCR as derived from the subject cataplexy diary over Weeks 5 and 6 by dose level, TEAEs by study period, Clinical laboratory assessments by study period, Vital signs by study period, Safety ECG by study period, C-SSRS by study period

Interventions

DRUGPlacebo to match ALKS 2680

DRUGALKS 2680

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in the MSL on MWT from baseline to Week 6 by dose level	—

Secondary

Measure	Time frame
Change in ESS from baseline to Week 6 by dose level, Mean WCR as derived from the subject cataplexy diary over Weeks 5 and 6 by dose level, TEAEs by study period, Clinical laboratory assessments by study period, Vital signs by study period, Safety ECG by study period, C-SSRS by study period	—

Countries

Belgium, Czechia, France, Italy, Netherlands, Spain

Outcome results

None listed

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