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NCT06767683PHASE2, PHASE3Recruiting

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

Alkermes, Inc.

Start Date

1/27/2025

Completion Date

6/1/2028

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 Criteria

Age Range: 18 years to 70 years

Inclusion Criteria: * Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible studies are ALKS 2680-201 (Vibrance-1), ALKS 2680-202 (Vibrance-2) and ALKS 2680-203 (Vibrance-3) * Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy symptoms, as applicable, for 5 half-lives prior to Day 1 (for re-entry subjects), and for the duration of study (for all subjects) Exclusion Criteria: * Developed a new clinically significant health condition, ECG or laboratory abnormality, in the opinion of the Investigator or Sponsor, may impact the subject's participation in the study * Is currently pregnant, breastfeeding, or planning to become pregnant during the study * Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening

Interventions

DRUG

ALKS 2680, 4mg

DRUG

ALKS 2680, 6mg

DRUG

ALKS 2680, 8mg

DRUG

ALKS 2680, 10mg

DRUG

ALKS 2680, 14mg

DRUG

ALKS 2680, 18mg

Interested in This Trial?

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Conditions

Narcolepsy Type 1Narcolepsy Type 2Idiopathic Hypersomnia

Locations

Alkermes Investigator Site

Phoenix, Arizona 85054

United States

Alkermes Investigational Site

Little Rock, Arkansas 72211

United States

Alkermes Investigational Site

Los Angeles, California 90025

United States

Alkermes Investigator Site

San Francisco, California 94158

United States

Alkermes Investigational Site

Stanford, California 94305

United States

Alkermes Investigational Site

Colorado Springs, Colorado 80918

United States

Alkermes Investigational Site

Brandon, Florida 33511

United States

Alkermes Investigational Site

Miami, Florida 33176

United States

Alkermes Investigational Site

Winter Park, Florida 32789

United States

Alkermes Investigational Site

Atlanta, Georgia 30328

United States

Alkermes Investigational Site

Macon, Georgia 31210

United States

Alkermes Investigational Site

Stockbridge, Georgia 30281

United States

Alkermes Investigational Site

Peoria, Illinois 61637

United States

Alkermes Investigational Site

Lansing, Michigan 48911

United States

Alkermes Investigational Site

Sterling Heights, Michigan 48314

United States

Alkermes Investigational Site

Lincoln, Nebraska 68506

United States

Alkermes Investigational Site

Middletown, New Jersey 07748

United States

Alkermes Investigational Site

Denver, North Carolina 28037

United States

Alkermes Investigational Site

Huntersville, North Carolina 28708

United States

Alkermes Investigational Site

Canton, Ohio 44718

United States

Alkermes Investigational Site

Cincinnati, Ohio 45212

United States

Alkermes Investigational Site

Cincinnati, Ohio 45245

United States

Alkermes Investigational Site

Dublin, Ohio 43017

United States

Alkermes Investigational Site

Abington, Pennsylvania 19001

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

Madison, Wisconsin 53706

United States

Alkermes Investigational Site

Sydney, New South Wales 2113

Australia

Alkermes Investigational Site

Bedford Park, South Australia 5042

Australia

Alkermes Investigational Site

Clayton, Victoria 3168

Australia

Alkermes Investigational Site

Bruges, Brugge 8000

Belgium

Alkermes Investigational Site

Alken, 3570

Belgium

Alkermes Investigational Site

Namur, 5101

Belgium

Alkermes Investigational Site

Prague, 128 21

Czechia

Alkermes Investigational Site

Montpellier, Herault 34295

France

Alkermes Investigational Site

Bordeaux, 33000

France

Alkermes Investigational Site

Bologna, 40139

Italy

Alkermes Investigational Site

Milan, 20127

Italy

Alkermes Investigational Site

Verona, 37134

Italy

Alkermes Investigational Site

Zwolle, 8025

Netherlands

Alkermes Investigational Site

Madrid, Madrid 28036

Spain

Alkermes Investigational Site

Barcelona, 08036

Spain

Alkermes Investigational Site

Madrid, 28043

Spain