RECRUITING

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

Description

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.

Conditions

Narcolepsy Type 1Narcolepsy Type 2Idiopathic Hypersomnia
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Related Conditions:

Narcolepsy Type 1Narcolepsy Type 2Idiopathic Hypersomnia

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Narcolepsy Type 1
Intervention / Treatment

-

Contacts and Locations

Little Rock

Alkermes Investigational Site, Little Rock, Arkansas, United States, 72211

Los Angeles

Alkermes Investigational Site, Los Angeles, California, United States, 90025

Stanford

Alkermes Investigational Site, Stanford, California, United States, 94305

Colorado Springs

Alkermes Investigational Site, Colorado Springs, Colorado, United States, 80918

Brandon

Alkermes Investigational Site, Brandon, Florida, United States, 33511

Miami

Alkermes Investigational Site, Miami, Florida, United States, 33176

Winter Park

Alkermes Investigational Site, Winter Park, Florida, United States, 32789

Atlanta

Alkermes Investigational Site, Atlanta, Georgia, United States, 30328

Macon

Alkermes Investigational Site, Macon, Georgia, United States, 31210

Stockbridge

Alkermes Investigational Site, Stockbridge, Georgia, United States, 30281

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alkermes, Inc.,

Medical Director, STUDY_DIRECTOR, Alkermes, Inc.

Study Record Dates

2028-06