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RECRUITING
NCT07455383
PHASE3

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

Sponsor: Alkermes, Inc.

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-04-06

Completion Date

2027-06

Last Updated

2026-07-02

Healthy Volunteers

No

Interventions

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.

Locations (22)

Alkermes Investigational Site

Cullman, Alabama, United States

Alkermes Investigational Site

Los Angeles, California, United States

Alkermes Investigational Site

Boulder, Colorado, United States

Alkermes Investigational Site

Brandon, Florida, United States

Alkermes Investigational Site

Miami, Florida, United States

Alkermes Investigational Site

Winter Park, Florida, United States

Alkermes Investigational Site

Macon, Georgia, United States

Alkermes Investigational Site

Kansas City, Kansas, United States

Alkermes Investigational Site

Newton, Massachusetts, United States

Alkermes Investigational Site

Lansing, Michigan, United States

Alkermes Investigational Site

St Louis, Missouri, United States

Alkermes Investigational Site

Middletown, New Jersey, United States

Alkermes Investigational Site

Cincinnati, Ohio, United States

Alkermes Investigational Site

Wyomissing, Pennsylvania, United States

Alkermes Investigational Site

Columbia, South Carolina, United States

Alkermes Investigational Site

Austin, Texas, United States

Alkermes Investigational Site

San Antonio, Texas, United States

Alkermes Investigational Site

Sugar Land, Texas, United States

Alkermes Investigational Site

Macquarie Park, New South Wales, Australia

Alkermes Investigational Site

Markham, Ontario, Canada

Alkermes Investigational Site

Toronto, Ontario, Canada

Alkermes Investigational Site

Zwolle, Overijssel, Netherlands