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NCT07502443PHASE3Recruiting

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

Alkermes, Inc.

Start Date

4/22/2026

Completion Date

6/1/2027

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.

Eligibility Criteria

Age Range: 18 years to 70 years

Inclusion Criteria: * Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including the following: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits. * Meets the diagnostic criteria of NT2 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT). Exclusion Criteria: * Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle. * Has a history or presence 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 2680-202 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

ALKS 2680 Dose 3

DRUG

Placebo

Interested in This Trial?

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Conditions

Narcolepsy Type 2

Locations

Alkermes Investigational Site

Cullman, Alabama 35055

United States

Alkermes Investigational Site

Los Angeles, California 90025

United States

Alkermes Investigational Site

Boulder, Colorado 80301

United States

Alkermes Investigational Site

Brandon, Florida 33511

United States

Alkermes Investigational Site

Maimi, Florida 33176

United States

Alkermes Investigational Site

Winter Park, Florida 32789

United States

Alkermes Investigational Site

Macon, Georgia 31210

United States

Alkermes Investigational Site

Kansas City, Kansas 66160

United States

Alkermes Investigational Site

Newton, Massachusetts 02459

United States

Alkermes Investigational Site

Lansing, Michigan 48911

United States

Alkermes Investigational Site

Huntersville, North Carolina 28078

United States

Alkermes Investigational Site

Cincinnati, Ohio 45245

United States

Alkermes Investigational Site

Wyomissing, Pennsylvania 19610

United States

Alkermes Investigational Site

Columbia, South Carolina 29201

United States

Alkermes Investigational Site

Austin, Texas 78731

United States

Alkermes Investigational Site

San Antonio, Texas 78229

United States

Alkermes Investigational Site

Sugar Land, Texas 77478

United States

Alkermes Investigational Site

Markham, Ontario L3R 1A3

Canada

Alkermes Investigational Site

Toronto, Ontario M5S 3A3

Canada