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 2

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515452-20-00

Acronym

ALKS 2680-202

Enrollment

124

Registered

2025-03-13

Start date

2025-04-01

Completion date

2025-11-11

Last updated

2026-01-13

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

Conditions

Narcolepsy Type 2

Brief summary

• Change in the MSL on MWT from baseline to Week 8 by dose level • Change in ESS from baseline to Week 8 by dose level

Detailed description

• 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 8 by dose level • Change in ESS from baseline to Week 8 by dose level	—

Secondary

Measure	Time frame
• 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