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Long-Term Study of ALKS 2680 for Narcolepsy and Idiopathic Hypersomnia

This study is looking at the long-term safety and effectiveness of a medication called ALKS 2680 for people with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH). ALKS 2680 is an oral tablet taken once daily, with different doses being studied (4mg, 6mg, 8mg, 10mg, 14mg). You can join this study if you are between 18 and 70 years old and have already completed a previous study with ALKS 2680 (Vibrance-1, Vibrance-2, or Vibrance-3). The main goal is to track any side effects you might experience while taking ALKS 2680 for up to 100 weeks. The study aims to enroll 256 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is designed to enroll 256 participants who have previously completed a study with ALKS 2680.
What's involved
You would take ALKS 2680 tablets once daily. The study will measure side effects for up to 100 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for the incidence of treatment-emergent adverse events for up to 100 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06767683

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

Recruiting
PHASE2Ages 18–70InterventionalTreatment
Alkermes, Inc.
~256 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:ALKS 2680, 4mgALKS 2680, 6mgALKS 2680, 8mgALKS 2680, 10mgALKS 2680, 14mgALKS 2680, 18mg

At a glance

Recruiting sites
49 of 49 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events
Measured over Up to 100 Weeks

Conditions

Narcolepsy Type 1
Narcolepsy Type 2
Idiopathic Hypersomnia

Explore related trials

Idiopathic HypersomniaNarcolepsy type 1Narcolepsy without Cataplexy

Where it's being run

49 sites across 30 states
Ohio4
California3
Florida3
Georgia3
Texas3
Italy3
Colorado2
Michigan2

Study leadership

  • Medical Director · STUDY_DIRECTOR · Alkermes, Inc.

Who to contact

Director, Global Clinical Services
[email protected]
888-235-8008 (US Only)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of Treatment-Emergent Adverse EventsUp to 100 Weeks