This study is in progress, not accepting new patients

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

a study on Idiopathic Hypersomnia

Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Andrew Krystal (ucsf)
Headshot of Andrew Krystal
Andrew Krystal

Description

Summary

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)

Keywords

Idiopathic Hypersomnia, IH, sleep, sleep disorder, orexin-2 receptor agonist, excessive daytime sleepiness, Sleep Wake Disorders, Disorders of Excessive Somnolence, ALKS 2680

Eligibility

You can join if…

Open to people ages 18-70

  • 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.
  • 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

You CAN'T join if...

  • Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle
  • 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
  • Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1
  • Is currently pregnant, breastfeeding, or is planning to become pregnant during the study

Locations

  • Alkermes Investigator Site
    San Francisco California 94143 United States
  • Alkermes Investigator Site
    Los Angeles California 90025 United States
  • Alkermes Investigator Site
    Redwood City California 94063 United States

Lead Scientist at University of California Health

  • Andrew Krystal (ucsf)
    Dr. Krystal is the Ray and Dagmar Dolby Distinguished Professor in the Departments of Psychiatry and Neurology, Vice-Chair for Research in the Department of Psychiatry, Director of the Dolby Family Center for Mood Disorders, Director of the UCSF Interventional Psychiatry Program and Director of the Clinical and Translational Sleep Research Laboratory.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Alkermes, Inc.
ID
NCT06843590
Phase
Phase 2 Idiopathic Hypersomnia Research Study
Study Type
Interventional
Participants
Expecting 126 study participants
Last Updated