RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-01-27
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06767683

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * 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)
  1. * 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
  2. * Is currently pregnant, breastfeeding, or planning to become pregnant during the study
  3. * 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

Contacts and Locations

Study Contact

Director, Global Clinical Services
CONTACT
888-235-8008 (US Only)
clinicaltrials@alkermes.com
Director, Global Clinical Services
CONTACT
571-599-2702 (Global)
clinicaltrials@alkermes.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Alkermes, Inc.

Study Locations (Sites)

Alkermes Investigational Site
Little Rock, Arkansas, 72211
United States
Alkermes Investigational Site
Los Angeles, California, 90025
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

Collaborators and Investigators

Sponsor: Alkermes, Inc.

  • Medical Director, STUDY_DIRECTOR, Alkermes, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-27
Study Completion Date2028-06

Study Record Updates

Study Start Date2025-01-27
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • Narcolepsy
  • Narcolepsy Type 1
  • Narcolepsy Type 2
  • NT1
  • NT2
  • orexin-2 receptor agonist
  • sleep
  • sleep disorder
  • excessive daytime sleepiness
  • IH
  • Idiopathic Hypersomnia

Additional Relevant MeSH Terms

  • Narcolepsy Type 1
  • Narcolepsy Type 2
  • Idiopathic Hypersomnia