NCT07455383

A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 Study 302)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (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, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.

Conditions

• Narcolepsy Type 1

Interventions

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

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-05-01
• Completion: 2027-06-01
• First posted: 2026-03-06
• Last updated: 2026-03-09

Regulatory

• FDA-regulated drug study