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A Study of ALKS 2680 for Narcolepsy Type 1

This study is testing a new medication called ALKS 2680 for adults with Narcolepsy Type 1 (NT1). Researchers want to see if ALKS 2680 can help reduce daytime sleepiness, sudden muscle weakness (cataplexy), and other symptoms of NT1. You would take ALKS 2680 tablets or a placebo (an inactive pill) daily for 12 weeks. The main way they will measure success is by looking at how much your sleepiness changes on a special test called the Maintenance of Wakefulness Test (MWT) after 12 weeks. Adults aged 18 to 70 with a confirmed diagnosis of NT1 can join this study, which plans to enroll 150 people.

Study design
This is an interventional study comparing two doses of ALKS 2680 to a placebo in about 150 participants.
What's involved
Participants will take tablets daily, orally, for 12 weeks. The primary endpoint is measured at Week 12.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at Week 12, indicating follow-up for at least that duration.

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

NCT07540897

A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)

Recruiting
PHASE3Ages 18–70InterventionalTreatment
Alkermes, Inc.
~150 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:ALKS 2680 Dose 1ALKS 2680 Dose 2Placebo

At a glance

Recruiting sites
14 of 14 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 1

Explore related trials

Narcolepsy type 1Orexin A

Where it's being run

14 sites across 9 states
Texas3
Florida2
Georgia2
Ontario2
Michigan1
Missouri1
North Carolina1
Ohio1

Study leadership

  • Medical 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

Meets the diagnostic criteria of NT1 according to ICSD-3-TR guidelines, confirmed by diagnostic evaluations (either PSG/MSLT\* or CSF hypocretin-1 level)

Exclusion

Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle.
Has a history or presence at Visit 1 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 2680-201 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