A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia (Vibrance-3)

February 10, 2026 updated by: Alkermes, Inc.

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2113
        • Recruiting
        • Alkermes Investigator Site
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Recruiting
        • Alkermes Investigator Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Alkermes Investigator Site
  • Belgium
      • Alken, Belgium, 3570
        • Recruiting
        • Alkermes Investigator Site
      • Namur, Belgium, 5101
        • Recruiting
        • Alkermes Investigator Site
  • Czechia
      • Prague, Czechia, 128 21
        • Recruiting
        • Alkermes Investigator Site
  • France
    • Gironde
      • Bordeaux, Gironde, France, 33000
        • Recruiting
        • Alkermes Investigator Site
    • Herault
      • Montpellier, Herault, France, 34295
        • Recruiting
        • Alkermes Investigator Site
    • Isere
      • Grenoble, Isere, France, 38043
        • Recruiting
        • Alkermes Investigator Site
  • Italy
      • Bologna, Italy, 40139
        • Recruiting
        • Alkermes Investigator Site
      • Milan, Italy, 20127
        • Recruiting
        • Alkermes Investigator Site
      • Verona, Italy, 37134
        • Recruiting
        • Alkermes Investigator Site
  • Netherlands
      • Zwolle, Netherlands, 8025 BV
        • Recruiting
        • Alkermes Investigator Site
  • Spain
      • Barcelona, Spain, 8036
        • Recruiting
        • Alkermes Investigator Site
      • Madrid, Spain, 28036
        • Recruiting
        • Alkermes Investigator Site
      • Madrid, Spain, 28043
        • Recruiting
        • Alkermes Investigator Site
  • United States
    • Alabama
      • Cullman, Alabama, United States, 35055
        • Recruiting
        • Alkermes Investigator Site
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Alkermes Investigator Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Alkermes Investigator Site
    • California
      • Los Angeles, California, United States, 90025
        • Recruiting
        • Alkermes Investigator Site
      • Redwood City, California, United States, 94063
        • Recruiting
        • Alkermes Investigator Site
      • San Francisco, California, United States, 94143
        • Recruiting
        • Alkermes Investigator Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80918
        • Recruiting
        • Alkermes Investigator Site
    • Florida
      • Brandon, Florida, United States, 33511
        • Recruiting
        • Alkermes Investigator Site
      • Miami, Florida, United States, 33176
        • Recruiting
        • Alkermes Investigator Site
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Alkermes Investigator Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Recruiting
        • Alkermes Investigator Site
      • Macon, Georgia, United States, 31210
        • Recruiting
        • Alkermes Investigator Site
      • Stockbridge, Georgia, United States, 30281
        • Recruiting
        • Alkermes Investigator Site
    • Illinois
      • Peoria, Illinois, United States, 61637
        • Recruiting
        • Alkermes Investigator Site
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • Alkermes Investigator Site
    • Michigan
      • Lansing, Michigan, United States, 48911
        • Recruiting
        • Alkermes Investigator Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Recruiting
        • Alkermes Investigator Site
    • New Jersey
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Alkermes Investigator Site
    • North Carolina
      • Denver, North Carolina, United States, 28037
        • Recruiting
        • Alkermes Investigator Site
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Alkermes Investigator Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Alkermes Investigator Site
      • Cincinnati, Ohio, United States, 45245
        • Recruiting
        • Alkermes Investigator Site
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Alkermes Investigator Site
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Alkermes Investigator Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Alkermes Investigator Site
      • Wyomissing, Pennsylvania, United States, 19610
        • Recruiting
        • Alkermes Investigator Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Recruiting
        • Alkermes Investigator Site
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Alkermes Investigator Site
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Alkermes Investigator Site
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • Alkermes Investigator Site
      • Sugarland, Texas, United States, 77478
        • Recruiting
        • Alkermes Investigator Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • Alkermes Investigator Site

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALKS 2680, 10 mg
Oral tablet containing 10 mg of ALKS 2680 for once daily administration
Drug: ALKS 2680
Oral tablet containing ALKS 2680 for once daily administration
Experimental: ALKS 2680, 14 mg
Oral tablet containing 14 mg of ALKS 2680 for once daily administration
Drug: ALKS 2680
Oral tablet containing ALKS 2680 for once daily administration
Experimental: ALKS 2680, 18 mg
Oral tablet containing 18 mg of ALKS 2680 for once daily administration
Drug: ALKS 2680
Oral tablet containing ALKS 2680 for once daily administration
Placebo Comparator: Placebo
Oral placebo tablet for once daily administration
Drug: Placebo
Oral placebo tablet for once daily administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level
Time Frame: Up to 8 weeks
Up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Idiopathic Hypersomnia Severity Scale (IHSS) from baseline to Week 8 by dose level
Time Frame: Up to 8 weeks
Up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkermes, Inc.

Investigators

  • Study Director: Medical 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 Major Dates

Study Start (Actual)

May 22, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

February 25, 2025

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALKS 2680-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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