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NCT06843590PHASE2Recruiting

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia

Alkermes, Inc.

Start Date

5/22/2025

Completion Date

11/1/2026

Summary

The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia 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: 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 Idiopathic Hypersomnia according to ICSD-3-TR guidelines, confirmed by the diagnostic evaluations (PSG/MSLT/actigraphy) within the previous 10 years 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 subject safety, interfere with any study assessment, or affect the subject's ability to complete the study * Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1 * Is currently pregnant, breastfeeding, or is planning to become pregnant during the study

Interventions

DRUG

ALKS 2680

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Idiopathic Hypersomnia

Locations

Alkermes Investigator Site

Cullman, Alabama 35055

United States

Alkermes Investigator Site

Phoenix, Arizona 85054

United States

Alkermes Investigator Site

Little Rock, Arkansas 72211

United States

Alkermes Investigator Site

Los Angeles, California 90025

United States

Alkermes Investigator Site

Redwood City, California 94063

United States

Alkermes Investigator Site

San Francisco, California 94143

United States

Alkermes Investigational Site

Boulder, Colorado 80301

United States

Alkermes Investigator Site

Colorado Springs, Colorado 80918

United States

Alkermes Investigator Site

Brandon, Florida 33511

United States

Alkermes Investigator Site

Miami, Florida 33176

United States

Alkermes Investigator Site

Winter Park, Florida 32789

United States

Alkermes Investigator Site

Atlanta, Georgia 30328

United States

Alkermes Investigator Site

Macon, Georgia 31210

United States

Alkermes Investigator Site

Stockbridge, Georgia 30281

United States

Alkermes Investigator Site

Peoria, Illinois 61637

United States

Alkermes Investigator Site

Kansas City, Kansas 66160

United States

Alkermes Investigational Site

Boston, Massachusetts 02215

United States

Alkermes Investigator Site

Lansing, Michigan 48911

United States

Alkermes Investigator Site

Lincoln, Nebraska 68506

United States

Alkermes Investigator Site

Middletown, New Jersey 07748

United States

Alkermes Investigator Site

Denver, North Carolina 28037

United States

Alkermes Investigator Site

Huntersville, North Carolina 28078

United States

Alkermes Investigator Site

Canton, Ohio 44718

United States

Alkermes Investigator Site

Cincinnati, Ohio 45245

United States

Alkermes Investigator Site

Cleveland, Ohio 44195

United States

Alkermes Investigator Site

Danville, Pennsylvania 17822

United States

Alkermes Investigator Site

Philadelphia, Pennsylvania 19107

United States

Alkermes Investigator Site

Wyomissing, Pennsylvania 19610

United States

Alkermes Investigator Site

Columbia, South Carolina 29201

United States

Alkermes Investigator Site

Austin, Texas 78731

United States

Alkermes Investigator Site

San Antonio, Texas 78229

United States

Alkermes Investigator Site

Sugar Land, Texas 77478

United States

Alkermes Investigator Site

Sugarland, Texas 77478

United States

Alkermes Investigator Site

Madison, Wisconsin 53792

United States

Alkermes Investigator Site

Sydney, New South Wales 2113

Australia

Alkermes Investigator Site

Bedford Park, South Australia 5042

Australia

Alkermes Investigator Site

Clayton, Victoria 3168

Australia

Alkermes Investigator Site

Alken, 3570

Belgium

Alkermes Investigator Site

Namur, 5101

Belgium

Alkermes Investigator Site

Prague, 128 21

Czechia

Alkermes Investigator Site

Bordeaux, Gironde 33000

France

Alkermes Investigator Site

Montpellier, Herault 34295

France

Alkermes Investigator Site

Grenoble, Isere 38043

France

Alkermes Investigator Site

Bologna, 40139

Italy

Alkermes Investigator Site

Milan, 20127

Italy

Alkermes Investigator Site

Verona, 37134

Italy

Alkermes Investigator Site

Zwolle, 8025 BV

Netherlands

Alkermes Investigator Site

Barcelona, 8036

Spain

Alkermes Investigator Site

Madrid, 28036

Spain

Alkermes Investigator Site

Madrid, 28043

Spain