RecruitingPhase 2NCT06843590

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

A Phase 2, Randomized, Parallel-Group, Double-Blind, Dose-Range-Finding Study to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Idiopathic Hypersomnia (Vibrance-3)

Sponsor

Alkermes, Inc.

Enrollment

126 participants

Start Date

May 22, 2025

Study Type

INTERVENTIONAL

Conditions

Idiopathic Hypersomnia

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ALKS 2680 and a drug called Placebo for people with idiopathic hypersomnia. The study is currently recruiting participants at 50 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

Oral tablet containing ALKS 2680 for daily, oral administration

DRUGPlacebo

Oral placebo tablet for daily administration

Locations(50)

Alkermes Investigator Site

Cullman, Alabama, United States

Alkermes Investigator Site

Phoenix, Arizona, United States

Alkermes Investigator Site

Little Rock, Arkansas, United States

Alkermes Investigator Site

Los Angeles, California, United States

Alkermes Investigator Site

Redwood City, California, United States

Alkermes Investigator Site

San Francisco, California, United States

Alkermes Investigational Site

Boulder, Colorado, United States

Alkermes Investigator Site

Colorado Springs, Colorado, United States

Alkermes Investigator Site

Brandon, Florida, United States

Alkermes Investigator Site

Miami, Florida, United States

Alkermes Investigator Site

Winter Park, Florida, United States

Alkermes Investigator Site

Atlanta, Georgia, United States

Alkermes Investigator Site

Macon, Georgia, United States

Alkermes Investigator Site

Stockbridge, Georgia, United States

Alkermes Investigator Site

Peoria, Illinois, United States

Alkermes Investigator Site

Kansas City, Kansas, United States

Alkermes Investigational Site

Boston, Massachusetts, United States

Alkermes Investigator Site

Lansing, Michigan, United States

Alkermes Investigator Site

Lincoln, Nebraska, United States

Alkermes Investigator Site

Middletown, New Jersey, United States

Alkermes Investigator Site

Denver, North Carolina, United States

Alkermes Investigator Site

Huntersville, North Carolina, United States

Alkermes Investigator Site

Canton, Ohio, United States

Alkermes Investigator Site

Cincinnati, Ohio, United States

Alkermes Investigator Site

Cleveland, Ohio, United States

Alkermes Investigator Site

Danville, Pennsylvania, United States

Alkermes Investigator Site

Philadelphia, Pennsylvania, United States

Alkermes Investigator Site

Wyomissing, Pennsylvania, United States

Alkermes Investigator Site

Columbia, South Carolina, United States

Alkermes Investigator Site

Austin, Texas, United States

Alkermes Investigator Site

San Antonio, Texas, United States

Alkermes Investigator Site

Sugar Land, Texas, United States

Alkermes Investigator Site

Sugarland, Texas, United States

Alkermes Investigator Site

Madison, Wisconsin, United States

Alkermes Investigator Site

Sydney, New South Wales, Australia

Alkermes Investigator Site

Bedford Park, South Australia, Australia

Alkermes Investigator Site

Clayton, Victoria, Australia

Alkermes Investigator Site

Alken, Belgium

Alkermes Investigator Site

Namur, Belgium

Alkermes Investigator Site

Prague, Czechia

Alkermes Investigator Site

Bordeaux, Gironde, France

Alkermes Investigator Site

Montpellier, Herault, France

Alkermes Investigator Site

Grenoble, Isere, France

Alkermes Investigator Site

Bologna, Italy

Alkermes Investigator Site

Milan, Italy

Alkermes Investigator Site

Verona, Italy

Alkermes Investigator Site

Zwolle, Netherlands

Alkermes Investigator Site

Barcelona, Spain

Alkermes Investigator Site

Madrid, Spain

Alkermes Investigator Site

Madrid, Spain

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NCT06843590

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