A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2 (Vibrance-2)

February 25, 2026 updated by: Alkermes, Inc.

A Phase 2, Parallel-Group, Dose-Range-Finding Study With Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Narcolepsy Type 2

The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

93

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 Locations

  • Australia
    • New South Wales
      • Macquarie Park, New South Wales, Australia, 2113
        • Alkermes Investigator Site
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Alkermes Investigator Site
  • Belgium
      • Alken, Belgium, 3570
        • Alkermes Investigational Site
      • Namur, Belgium, 5101
        • Alkermes Investigational Site
  • Czechia
      • Prague, Czechia, 128 21
        • Alkermes Investigational Site
  • France
      • Bordeaux, France, 33076
        • Alkermes Investigational Site
      • La Tronche, France, 38700
        • Alkermes Investigational Site
  • Italy
      • Verona, Italy, 37134
        • Alkermes Investigational Site
    • BO
      • Bologna, BO, Italy, 40139
        • Alkermes Investigational Site
    • Metropolitan City Of Milan
      • Milan, Metropolitan City Of Milan, Italy, 20132
        • Alkermes Investigational Site
  • Netherlands
      • Zwolle, Netherlands, 8025BV
        • Alkermes Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Alkermes Investigational Site
      • Madrid, Spain, 28036
        • Alkermes Investigational Site
      • Madrid, Spain, 28043
        • Alkermes Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Alkermes Investigator Site
    • California
      • Los Angeles, California, United States, 90025
        • Alkermes Investigator Site
      • Redwood City, California, United States, 94063
        • Alkermes Investigator Site
      • San Francisco, California, United States, 94143
        • Alkermes Investigator Site
      • Santa Ana, California, United States, 92705
        • Alkermes Investigator Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Alkermes Investigational Site
      • Colorado Springs, Colorado, United States, 80918
        • Alkermes Investigator Site
    • Florida
      • Brandon, Florida, United States, 33511
        • Alkermes Investigator Site
      • Miami, Florida, United States, 33176
        • Alkermes Investigator Site
      • Winter Park, Florida, United States, 32789
        • Alkermes Investigator Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Alkermes Investigator Site
      • Macon, Georgia, United States, 31210
        • Alkermes Investigational Site
      • Stockbridge, Georgia, United States, 30281
        • Alkermes Investigator Site
    • Illinois
      • Peoria, Illinois, United States, 61637
        • Alkermes Investigational Site
    • Michigan
      • Lansing, Michigan, United States, 48911
        • Alkermes Investigator Site
      • Sterling Heights, Michigan, United States, 48314
        • Alkermes Investigator Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Alkermes Investigator Site
    • New Jersey
      • Middletown, New Jersey, United States, 07748
        • Alkermes Investigator Site
    • North Carolina
      • Denver, North Carolina, United States, 28037
        • Alkermes Investigator Site
      • Huntersville, North Carolina, United States, 28078
        • Alkermes Investigator Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Alkermes Investigator Site
      • Cincinnati, Ohio, United States, 45212
        • Alkermes Investigator Site
      • Cincinnati, Ohio, United States, 45245
        • Alkermes Investigator Site
      • Cleveland, Ohio, United States, 44195
        • Alkermes Investigational Site
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Alkermes Investigator Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Alkermes Investigational Site
      • Wyomissing, Pennsylvania, United States, 19610
        • Alkermes Investigator Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Alkermes Investigator Site
    • Tennessee
      • Cordova, Tennessee, United States, 38108
        • Alkermes Investigator Site
    • Texas
      • Austin, Texas, United States, 78731
        • Alkermes Investigator Site
      • San Antonio, Texas, United States, 78229
        • Alkermes Investigator Site
      • Sugar Land, Texas, United States, 77478
        • Alkermes Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Alkermes Investigational 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:

  • 18-70 years of age
  • Has a BMI ≥18 and ≤40 kg/m2
  • Meets the diagnostic criteria of Narcolepsy type 2 according to ICSD-3-TR guidelines.

Additionally, meets the following criteria:

  • Has residual excessive daytime sleepiness
  • Is willing and able to discontinue any medications prescribed for the management of narcolepsy symptoms for at least 14 days and for the duration of study
  • Is willing to adhere to additional protocol requirements

Exclusion Criteria:

  • Significant comorbid medical conditions, including other sleep, cardiovascular, psychiatric, hepatic or other disorders may be exclusionary; eligibility will be determined on an individual basis by the study investigator
  • 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

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: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mean Sleep Latency (MSL) on the Maintenance Wakefulness Test (MWT)
Time Frame: Baseline to Week 8
Baseline to Week 8
Change in Epworth Sleepiness Scale (ESS)
Time Frame: Baseline to week 8
Participants will be asked to complete the ESS, reporting on the level of sleepiness they experienced over the past 7 days.
Baseline to week 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: Up to 21 weeks
Up to 21 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, MD, Alkermes, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

July 26, 2024

Primary Completion (Actual)

November 11, 2025

Study Completion (Actual)

November 21, 2025

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALKS 2680-202

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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