RecruitingPhase 2Phase 3NCT06767683

A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia

An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia


Sponsor

Alkermes, Inc.

Enrollment

256 participants

Start Date

Jan 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 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, 10mg, a drug called ALKS 2680, 14mg, and others for people with idiopathic hypersomnia, narcolepsy type 1, and other related conditions. The study is currently recruiting participants at 46 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, 4mg

Oral tablet containing 4 mg of ALKS 2680 for once daily administration

DRUGALKS 2680, 6mg

Oral tablet containing 6 mg of ALKS 2680 for once daily administration

DRUGALKS 2680, 8mg

Oral tablet containing 8 mg of ALKS 2680 for once daily administration

DRUGALKS 2680, 10mg

Oral tablet containing 10 mg of ALKS 2680 for once daily administration

DRUGALKS 2680, 14mg

Oral tablet containing 14 mg of ALKS 2680 for once daily administration

DRUGALKS 2680, 18mg

Oral tablet containing 18 mg of ALKS 2680 for once daily administration


Locations(46)

Alkermes Investigator Site

Phoenix, Arizona, United States

Alkermes Investigational Site

Little Rock, Arkansas, United States

Alkermes Investigational Site

Los Angeles, California, United States

Alkermes Investigator Site

San Francisco, California, United States

Alkermes Investigational Site

Stanford, California, United States

Alkermes Investigational Site

Colorado Springs, Colorado, United States

Alkermes Investigational Site

Brandon, Florida, United States

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

Stockbridge, Georgia, United States

Alkermes Investigational Site

Peoria, Illinois, United States

Alkermes Investigational Site

Lansing, Michigan, United States

Alkermes Investigational Site

Sterling Heights, Michigan, United States

Alkermes Investigational Site

Lincoln, Nebraska, United States

Alkermes Investigational Site

Middletown, New Jersey, United States

Alkermes Investigational Site

Denver, North Carolina, United States

Alkermes Investigational Site

Huntersville, North Carolina, United States

Alkermes Investigational Site

Canton, Ohio, United States

Alkermes Investigational Site

Cincinnati, Ohio, United States

Alkermes Investigational Site

Cincinnati, Ohio, United States

Alkermes Investigational Site

Dublin, Ohio, United States

Alkermes Investigational Site

Abington, Pennsylvania, United States

Alkermes Investigational Site

Wyomissing, Pennsylvania, United States

Alkermes Investigational Site

Columbia, South Carolina, United States

Alkermes Investigational Site

Austin, Texas, United States

Alkermes Investigational Site

San Antonio, Texas, United States

Alkermes Investigational Site

Sugar Land, Texas, United States

Alkermes Investigational Site

Madison, Wisconsin, United States

Alkermes Investigational Site

Sydney, New South Wales, Australia

Alkermes Investigational Site

Bedford Park, South Australia, Australia

Alkermes Investigational Site

Clayton, Victoria, Australia

Alkermes Investigational Site

Bruges, Brugge, Belgium

Alkermes Investigational Site

Alken, Belgium

Alkermes Investigational Site

Namur, Belgium

Alkermes Investigational Site

Prague, Czechia

Alkermes Investigational Site

Montpellier, Herault, France

Alkermes Investigational Site

Bordeaux, France

Alkermes Investigational Site

Bologna, Italy

Alkermes Investigational Site

Milan, Italy

Alkermes Investigational Site

Verona, Italy

Alkermes Investigational Site

Zwolle, Netherlands

Alkermes Investigational Site

Madrid, Madrid, Spain

Alkermes Investigational Site

Barcelona, Spain

Alkermes Investigational Site

Madrid, Spain

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NCT06767683


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