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Clinical Trials in the EU / 2025-523912-35-00
Completed Phase III

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2

2025-523912-35-00 · tracked via the Priya Life Science EU tracker
Sponsor
Alkermes Inc.
Sponsor type
Pharmaceutical company
Therapeutic area
Nervous System Diseases
Decision date
04/06/2026
Enrollment target
132
Sites
Spain, Netherlands, Belgium, Italy, France, Austria, Czechia, Germany, Sweden, Poland

Condition studied

Narcolepsy Type 2

Investigational medicinal product(s)

ALKS 2680Placebo to match ALKS 2680ALKS 2680ALKS 2680

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

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

Endpoint detail

Change in mean sleep latency on Maintenance of Wakefulness Test from baseline to Week 12 by dose level, Change in select patient-reported outcome measures from baseline to Week 12 by dose level.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523912-35-00 on CTIS ↗ ← All trials in the EU