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A Study of ALKS 2680 for Narcolepsy Type 2

This study is looking at how well ALKS 2680 tablets work and if they are safe for adults with Narcolepsy Type 2 (NT2). Participants will take ALKS 2680 or a placebo (an inactive pill) once a day for 12 weeks. The main goal is to see if ALKS 2680 helps reduce daytime sleepiness, measured by how long you can stay awake during a specific test. The study is open to adults aged 18 to 70. Researchers plan to enroll 176 people. The current status of this study is unclear, so it's not known if they are actively recruiting.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 176 participants.
What's involved
You would take ALKS 2680 tablets or a placebo daily for 12 weeks. You would also need to follow lifestyle guidelines, contraception advice, and track your activity and symptoms.
Compensation
Not stated in the trial record.
Follow-up
The main measurement for the study is taken at Week 12.

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

NCT07502443

A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2

Recruiting
PHASE3Ages 18–70InterventionalTreatment
Alkermes, Inc.
~176 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:ALKS 2680 Dose 1ALKS 2680 Dose 2ALKS 2680 Dose 3Placebo

At a glance

Recruiting sites
27 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose level
Measured over Baseline to Week 12

Conditions

Narcolepsy Type 2

Explore related trials

Narcolepsy without Cataplexy

Where it's being run

28 sites across 19 states
Florida3
Texas3
France3
Georgia2
North Carolina2
Ontario2
Alabama1
California1

Study leadership

  • Study Director, MD · STUDY_DIRECTOR · Alkermes, Inc.

Who to contact

Director Clinical Trial Manager
[email protected]
888-235-8008 (US Only)
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including the following: 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 NT2 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT).

Exclusion

Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle.
Has a history or presence of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise participant safety, interfere with any study assessment, or affect the participant's ability to complete the study.
Is currently enrolled in another interventional clinical trial or has received any investigational drug or used any interventional investigational device within 30 days prior to Visit 1. Participants previously enrolled in Study ALKS 2680-202 are not eligible for enrollment.
Is currently pregnant, breastfeeding, or is planning to become pregnant during the study

What this trial measures

  • Change in mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT) from baseline to Week 12 by dose levelBaseline to Week 12