A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia

March 3, 2026 updated by: Alkermes, Inc.

An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia

The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

256

Phase

  • Phase 2
  • Phase 3

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 Investigational Site
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Recruiting
        • Alkermes Investigational Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Alkermes Investigational Site
  • Belgium
      • Alken, Belgium, 3570
        • Recruiting
        • Alkermes Investigational Site
      • Namur, Belgium, 5101
        • Recruiting
        • Alkermes Investigational Site
    • Brugge
      • Bruges, Brugge, Belgium, 8000
        • Recruiting
        • Alkermes Investigational Site
  • Czechia
      • Prague, Czechia, 128 21
        • Recruiting
        • Alkermes Investigational Site
  • France
      • Bordeaux, France, 33000
        • Recruiting
        • Alkermes Investigational Site
    • Herault
      • Montpellier, Herault, France, 34295
        • Recruiting
        • Alkermes Investigational Site
  • Italy
      • Bologna, Italy, 40139
        • Recruiting
        • Alkermes Investigational Site
      • Milan, Italy, 20127
        • Recruiting
        • Alkermes Investigational Site
      • Verona, Italy, 37134
        • Recruiting
        • Alkermes Investigational Site
  • Netherlands
      • Zwolle, Netherlands, 8025
        • Recruiting
        • Alkermes Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Alkermes Investigational Site
      • Madrid, Spain, 28043
        • Recruiting
        • Alkermes Investigational Site
    • Madrid
      • Madrid, Madrid, Spain, 28036
        • Recruiting
        • Alkermes Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Alkermes Investigator Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Alkermes Investigational Site
    • California
      • Los Angeles, California, United States, 90025
        • Recruiting
        • Alkermes Investigational Site
      • San Francisco, California, United States, 94158
        • Recruiting
        • Alkermes Investigator Site
      • Stanford, California, United States, 94305
        • Recruiting
        • Alkermes Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80918
        • Recruiting
        • Alkermes Investigational Site
    • Florida
      • Brandon, Florida, United States, 33511
        • Recruiting
        • Alkermes Investigational Site
      • Miami, Florida, United States, 33176
        • Recruiting
        • Alkermes Investigational Site
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Alkermes Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Recruiting
        • Alkermes Investigational Site
      • Macon, Georgia, United States, 31210
        • Recruiting
        • Alkermes Investigational Site
      • Stockbridge, Georgia, United States, 30281
        • Recruiting
        • Alkermes Investigational Site
    • Illinois
      • Peoria, Illinois, United States, 61637
        • Recruiting
        • Alkermes Investigational Site
    • Michigan
      • Lansing, Michigan, United States, 48911
        • Recruiting
        • Alkermes Investigational Site
      • Sterling Heights, Michigan, United States, 48314
        • Recruiting
        • Alkermes Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Recruiting
        • Alkermes Investigational Site
    • New Jersey
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Alkermes Investigational Site
    • North Carolina
      • Denver, North Carolina, United States, 28037
        • Recruiting
        • Alkermes Investigational Site
      • Huntersville, North Carolina, United States, 28708
        • Recruiting
        • Alkermes Investigational Site
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Alkermes Investigational Site
      • Cincinnati, Ohio, United States, 45245
        • Recruiting
        • Alkermes Investigational Site
      • Cincinnati, Ohio, United States, 45212
        • Recruiting
        • Alkermes Investigational Site
      • Dublin, Ohio, United States, 43017
        • Recruiting
        • Alkermes Investigational Site
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Recruiting
        • Alkermes Investigational Site
      • Wyomissing, Pennsylvania, United States, 19610
        • Recruiting
        • Alkermes Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Recruiting
        • Alkermes Investigational Site
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Alkermes Investigational Site
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Alkermes Investigational Site
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • Alkermes Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53706
        • Recruiting
        • 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:

  • Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible studies are ALKS 2680-201 (Vibrance-1), ALKS 2680-202 (Vibrance-2) and ALKS 2680-203 (Vibrance-3)
  • Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy symptoms, as applicable, for 5 half-lives prior to Day 1 (for re-entry subjects), and for the duration of study (for all subjects)

Exclusion Criteria:

  • Developed a new clinically significant health condition, ECG or laboratory abnormality, in the opinion of the Investigator or Sponsor, may impact the subject's participation in the study
  • 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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Narcolepsy Type 1 (NT1)
Drug: ALKS 2680, 4mg
Oral tablet containing 4 mg of ALKS 2680 for once daily administration
Drug: ALKS 2680, 6mg
Oral tablet containing 6 mg of ALKS 2680 for once daily administration
Drug: ALKS 2680, 8mg
Oral tablet containing 8 mg of ALKS 2680 for once daily administration
Experimental: Narcolepsy Type 2 (NT2)
Drug: ALKS 2680, 10mg
Oral tablet containing 10 mg of ALKS 2680 for once daily administration
Drug: ALKS 2680, 14mg
Oral tablet containing 14 mg of ALKS 2680 for once daily administration
Drug: ALKS 2680, 18mg
Oral tablet containing 18 mg of ALKS 2680 for once daily administration
Experimental: Idiopathic Hypersomnia (IH)
Drug: ALKS 2680, 10mg
Oral tablet containing 10 mg of ALKS 2680 for once daily administration
Drug: ALKS 2680, 14mg
Oral tablet containing 14 mg of ALKS 2680 for once daily administration
Drug: ALKS 2680, 18mg
Oral tablet containing 18 mg of ALKS 2680 for once daily administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: Up to 100 Weeks
Up to 100 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT)
Time Frame: Baseline to Week 24
Baseline to Week 24
Change in Epworth Sleepiness Scale (ESS)
Time Frame: Baseline to 96 Weeks
Baseline to 96 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)

January 27, 2025

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

January 10, 2025

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALKS 2680-301

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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