ClinicalTrials.gg
CompletedNCT06555783Vibrance-2Updated Feb 27, 2026

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

A Phase 2 interventional study of ALKS 2680 and Placebo in Narcolepsy Type 2, sponsored by Alkermes, Inc.. Completed at 47 sites in 8 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by Alkermes, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2025, 1 year ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Narcolepsy Type 2

Keywords

  • Narcolepsy
  • Narcolepsy Type 2
  • NT2
  • Orexin-2 receptor agonist
  • Sleep
  • Sleep disorder
  • Excessive daytime sleepiness
03

In context

Narcolepsy

157 studies on the registry are indexed under Narcolepsy; 37 are open to participants now.

This study's enrollment of 93 is above the median of 78 across 114 interventional studies indexed under Narcolepsy.

Browse Narcolepsy studies →

Lead sponsor

Alkermes, Inc. is the lead sponsor of 83 studies on the registry; 9 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18-70 years of age
  • Has a ≥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

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 drug or device within 30 days prior to Screening
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
93 participants (actual)

Study arms

  • Experimental
    ALKS 2680, 10 mg

    Oral tablet containing 10mg of ALKS 2680 for once daily administration

    Drug: ALKS 2680

  • Experimental
    ALKS 2680, 14 mg

    Oral tablet containing 14mg of ALKS 2680 for once daily administration

    Drug: ALKS 2680

  • Experimental
    ALKS 2680, 18 mg

    Oral tablet containing 18mg of ALKS 2680 for once daily administration

    Drug: ALKS 2680

  • Placebo comparator
    Placebo

    Oral tablet containing matching placebo for once daily administration

    Drug: Placebo

Interventions

  • Oral tablet containing ALKS 2680

  • DrugPlacebo

    Oral tablet containing placebo for once daily administration

06

What researchers measure

Primary outcomes

  1. Change in Mean Sleep Latency (MSL) on the Maintenance Wakefulness Test (MWT)

    Time frame: Baseline to Week 8

  2. Change in Epworth Sleepiness Scale (ESS)

    Participants will be asked to complete the ESS, reporting on the level of sleepiness they experienced over the past 7 days.

    Time frame: Baseline to week 8

Secondary outcomes

  1. Incidence of adverse events

    Time frame: Up to 21 weeks

07

Study locations

47 sites
  • Alkermes Investigator Site
    Little Rock, Arkansas 72211, United States
  • Alkermes Investigator Site
    Los Angeles, California 90025, United States
  • Alkermes Investigator Site
    Redwood City, California 94063, United States
  • Alkermes Investigator Site
    San Francisco, California 94143, United States
  • Alkermes Investigator Site
    Santa Ana, California 92705, United States
  • Alkermes Investigational Site
    Aurora, Colorado 80045, United States
  • Alkermes Investigator Site
    Colorado Springs, Colorado 80918, United States
  • Alkermes Investigator Site
    Brandon, Florida 33511, United States
  • Alkermes Investigator Site
    Miami, Florida 33176, United States
  • Alkermes Investigator Site
    Winter Park, Florida 32789, United States
  • Alkermes Investigator Site
    Atlanta, Georgia 30328, United States
  • Alkermes Investigational Site
    Macon, Georgia 31210, United States
  • Alkermes Investigator Site
    Stockbridge, Georgia 30281, United States
  • Alkermes Investigational Site
    Peoria, Illinois 61637, United States
  • Alkermes Investigator Site
    Lansing, Michigan 48911, United States
  • Alkermes Investigator Site
    Sterling Heights, Michigan 48314, United States
  • Alkermes Investigator Site
    Lincoln, Nebraska 68506, United States
  • Alkermes Investigator Site
    Middletown, New Jersey 07748, United States
  • Alkermes Investigator Site
    Denver, North Carolina 28037, United States
  • Alkermes Investigator Site
    Huntersville, North Carolina 28078, United States
  • Alkermes Investigator Site
    Canton, Ohio 44718, United States
  • Alkermes Investigator Site
    Cincinnati, Ohio 45212, United States
  • Alkermes Investigator Site
    Cincinnati, Ohio 45245, United States
  • Alkermes Investigational Site
    Cleveland, Ohio 44195, United States
  • Alkermes Investigator Site
    Abington, Pennsylvania 19001, United States
  • Alkermes Investigational Site
    Philadelphia, Pennsylvania 19107, United States
  • Alkermes Investigator Site
    Wyomissing, Pennsylvania 19610, United States
  • Alkermes Investigator Site
    Columbia, South Carolina 29201, United States
  • Alkermes Investigator Site
    Cordova, Tennessee 38108, United States
  • Alkermes Investigator Site
    Austin, Texas 78731, United States
  • Alkermes Investigator Site
    San Antonio, Texas 78229, United States
  • Alkermes Investigational Site
    Sugar Land, Texas 77478, United States
  • Alkermes Investigational Site
    Madison, Wisconsin 53792, United States
  • Alkermes Investigator Site
    Macquarie Park, New South Wales 2113, Australia
  • Alkermes Investigator Site
    Bedford Park, South Australia 5042, Australia
  • Alkermes Investigational Site
    Alken, 3570, Belgium
  • Alkermes Investigational Site
    Namur, 5101, Belgium
  • Alkermes Investigational Site
    Prague, 128 21, Czechia
  • Alkermes Investigational Site
    Bordeaux, 33076, France
  • Alkermes Investigational Site
    La Tronche, 38700, France
  • Alkermes Investigational Site
    Bologna, BO 40139, Italy
  • Alkermes Investigational Site
    Milan, Metropolitan City Of Milan 20132, Italy
  • Alkermes Investigational site
    Verona, 37134, Italy
  • Alkermes Investigational Site
    Zwolle, 8025BV, Netherlands
  • Alkermes Investigational Site
    Barcelona, 08036, Spain
  • Alkermes Investigational Site
    Madrid, 28036, Spain
  • Alkermes Investigational Site
    Madrid, 28043, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06555783
Lead sponsor
Alkermes, Inc.
Responsible party
Sponsor
First posted
Aug 15, 2024
Start date
Jul 26, 2024
Primary completion
Nov 11, 2025
Completion
Nov 21, 2025
Last update
Feb 27, 2026

Study contacts

Medical Director, MD
study director · Alkermes, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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