RECRUITING

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

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Conditions

Idiopathic HypersomniaIHsleepsleep disorderorexin-2 receptor agonistexcessive daytime sleepiness

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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 measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets

Official Title

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)

Quick Facts

Study Start:2025-04
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06843590

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. * Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits.
  2. * Meets the diagnostic criteria of Idiopathic Hypersomnia according to ICSD-3-TR guidelines, confirmed by the diagnostic evaluations (PSG/MSLT/actigraphy) within the previous 10 years
  1. * Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle
  2. * Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject's ability to complete the study
  3. * Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1
  4. * Is currently pregnant, breastfeeding, or is planning to become pregnant during the study

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
Huntersville, North Carolina, 28078
United States
Alkermes Investigational Site
Columbia, South Carolina, 29201
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 Date2025-04
Study Completion Date2026-06

Study Record Updates

Study Start Date2025-04
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • Idiopathic Hypersomnia
  • IH
  • sleep
  • sleep disorder
  • orexin-2 receptor agonist
  • excessive daytime sleepiness

Additional Relevant MeSH Terms

  • Idiopathic Hypersomnia