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Clinical Trials in the USA / NCT07540897
Recruiting Phase 3

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

NCT07540897 · tracked via the Priya Life Science USA tracker
Sponsor
Alkermes, Inc.
Phase
Phase 3
Started
2026-08-13
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, daily, orally, for 12 weeks

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

Placebo: Participants will receive placebo tablets, daily, 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 (17)

FacilityCityRegionStatus
Alkermes Investigational Site Brandon Florida Recruiting
Alkermes Investigational Site Miami Florida Recruiting
Alkermes Investigational Site Winter Park Florida Recruiting
Alkermes Investigational Site Atlanta Georgia Recruiting
Alkermes Investigational Site Macon Georgia Recruiting
Alkermes Investigational Site Lansing Michigan Recruiting
Alkermes Investigational Site St Louis Missouri Recruiting
Alkermes Investigational Site Charlotte North Carolina Recruiting
Alkermes Investigational Site Cincinnati Ohio Recruiting
Alkermes Investigational Site Colombia South Carolina Recruiting
Alkermes Investigational Site Dallas Texas Recruiting
Alkermes Investigational Site Frisco Texas Recruiting
Alkermes Investigational Site San Antonio Texas Recruiting
Alkermes Investigational Site Sugar Land Texas Recruiting
Alkermes Investigational Site Markham Ontario Recruiting
Alkermes Investigational Site Toronto Ontario Recruiting
Alkermes Investigational Site Krakow Poland Recruiting

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 NCT07540897 on ClinicalTrials.gov ↗ ← All trials in the USA