RecruitingPhase 3NCT07540897

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

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 304)


Sponsor

Alkermes, Inc.

Enrollment

150 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ALKS 2680 Dose 1, a drug called ALKS 2680 Dose 2, and others for people with narcolepsy type 1. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGALKS 2680 Dose 1

Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks

DRUGALKS 2680 Dose 2

Participants will receive ALKS 2680 tablets, daily, orally, for 12 weeks

DRUGPlacebo

Participants will receive placebo tablets, daily, orally for 12 weeks


Locations(10)

Alkermes Investigational Site

Miami, Florida, United States

Alkermes Investigational Site

Winter Park, Florida, United States

Alkermes Investigational Site

Atlanta, Georgia, United States

Alkermes Investigational Site

Macon, Georgia, United States

Alkermes Investigational Site

Lansing, Michigan, United States

Alkermes Investigational Site

St Louis, Missouri, United States

Alkermes Investigational Site

Cincinnati, Ohio, United States

Alkermes Investigational Site

Dallas, Texas, United States

Alkermes Investigational Site

San Antonio, Texas, United States

Alkermes Investigational Site

Sugar Land, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07540897


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