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NCT07540897PHASE3Recruiting

A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)

Alkermes, Inc.

Start Date

6/1/2026

Completion Date

7/1/2027

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.

Eligibility Criteria

Age Range: 18 years to 70 years

Inclusion Criteria: * Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT\* or CSF hypocretin-1 level) Exclusion Criteria: * Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle. * Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise participant safety, interfere with any study assessment, or affect the participant's ability to complete the study. * Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-201 are not eligible for enrollment. * Is currently pregnant, breastfeeding, or is planning to become pregnant during the study.

Interventions

DRUG

ALKS 2680 Dose 1

DRUG

ALKS 2680 Dose 2

DRUG

Placebo

Interested in This Trial?

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Conditions

Narcolepsy Type 1

Locations

Alkermes Investigational Site

Miami, Florida 33176

United States

Alkermes Investigational Site

Winter Park, Florida 32789

United States

Alkermes Investigational Site

Atlanta, Georgia 30328

United States

Alkermes Investigational Site

Macon, Georgia 31210

United States

Alkermes Investigational Site

Lansing, Michigan 48911

United States

Alkermes Investigational Site

St Louis, Missouri 63123

United States

Alkermes Investigational Site

Cincinnati, Ohio 45245

United States

Alkermes Investigational Site

Dallas, Texas 75251

United States

Alkermes Investigational Site

San Antonio, Texas 78229

United States

Alkermes Investigational Site

Sugar Land, Texas 77478

United States