NCT07502443

A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 (Brilliance NT2 Study 303)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to measure decreases in daytime sleepiness, and disease symptoms in participants with Narcolepsy Type 2 (NT2) when taking ALKS 2680 tablets compared with placebo tablets.

Conditions

• Narcolepsy Type 2

Interventions

Type	Name	Description
DRUG	ALKS 2680 Dose 1	Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
DRUG	ALKS 2680 Dose 2	Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
DRUG	ALKS 2680 Dose 3	Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks
DRUG	Placebo	Participants will receive placebo tablets, daily, orally for 12 weeks

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-05-01
• Completion: 2027-06-01
• First posted: 2026-03-31
• Last updated: 2026-03-31

Regulatory

• FDA-regulated drug study