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Clinical Trials in the USA / NCT07455383
Recruiting Phase 3

A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

NCT07455383 · tracked via the Priya Life Science USA tracker
Sponsor
Alkermes, Inc.
Phase
Phase 3
Started
2026-04-06
Last updated
2026-09-03

Condition(s) studied

Narcolepsy Type 1

Investigational drug(s) / intervention(s)

ALKS 2680 Dose 1ALKS 2680 Dose 2Placebo

ALKS 2680 Dose 1: Participants will receive ALKS 2680 tablets, orally, daily, for 12 weeks

ALKS 2680 Dose 2: Participants will receive ALKS 2680 tablets, orally, daily, for 12 weeks

Placebo: Participants will receive ALKS 2680-matching placebo tablets, orally, for 12 weeks.

Study summary

The purpose of this study is to measure decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (42)

FacilityCityRegionStatus
Alkermes Investigational Site Cullman Alabama Recruiting
Alkermes Investigational Site Phoenix Arizona Recruiting
Alkermes Investigational Site Los Angeles California Recruiting
Alkermes Investigational Site Boulder Colorado Recruiting
Alkermes Investigational Site Brandon Florida Recruiting
Alkermes Investigational Site Miami Florida Recruiting
Alkermes Investigational Site Winter Park Florida Recruiting
Alkermes Investigational Site Macon Georgia Recruiting
Alkermes Investigational Site Kansas City Kansas Recruiting
Alkermes Investigational Site Newton Massachusetts Recruiting
Alkermes Investigational Site Lansing Michigan Recruiting
Alkermes Investigational Site Novi Michigan Recruiting
Alkermes Investigational Site St Louis Missouri Recruiting
Alkermes Investigational Site Middletown New Jersey Recruiting
Alkermes Investigational Site Charlotte North Carolina Recruiting
Alkermes Investigational Site Cincinnati Ohio Recruiting
Alkermes Investigational Site Wyomissing Pennsylvania Recruiting
Alkermes Investigational Site Columbia South Carolina Recruiting
Alkermes Investigational Site Austin Texas Recruiting
Alkermes Investigational Site San Antonio Texas Recruiting
Alkermes Investigational Site Sugar Land Texas Recruiting
Alkermes Investigational Site Madison Wisconsin Recruiting
Alkermes Investigational Site Macquarie Park New South Wales Recruiting
Alkermes Investigational Site Bruges Belgium Recruiting
Alkermes Investigational Site Edegem Belgium Recruiting
Alkermes Investigational Site Namur Belgium Recruiting
Alkermes Investigational Site Markham Ontario Recruiting
Alkermes Investigational Site Toronto Ontario Recruiting
Alkermes Investigational Site Bordeaux France Recruiting
Alkermes Investigational Site Lyon France Recruiting
Alkermes Investigational Site Montpellier France Recruiting
Alkermes Investigational Site Verona Italy Recruiting
Alkermes Investigational Site Kitakyushu-shi Fukuoka Recruiting
Alkermes Investigational Site Osaka Osaka Recruiting
Alkermes Investigational Site Shibuya-ku Tokyo-To Recruiting
Alkermes Investigational Site Shinjuku-Ku Tokyo-To Recruiting
Alkermes Investigational Site Kumamoto Japan Recruiting
Alkermes Investigational Site Zwolle Overijssel Recruiting
Alkermes Investigational Site Heeze Netherlands Recruiting
Alkermes Investigational Site Vitoria-Gasteiz Alava Recruiting

+ 2 more sites — see the full list on the official registry below.

More Alkermes, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07455383 on ClinicalTrials.gov ↗ ← All trials in the USA