Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT07455383

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

Led by Alkermes, Inc. · Updated on 2026-05-14

150

Participants Needed

9

Research Sites

60 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 70 years
  • Diagnosis of Narcolepsy Type 1 according to ICSD-3-TR guidelines, confirmed by PSG/MSLT or CSF hypocretin-1 level
Not Eligible

You will not qualify if you...

  • Presence of other sleep disorders or conditions affecting the sleep-wake cycle
  • Clinically significant illness, disease, abnormality, or surgical procedure that may affect safety or study participation
  • Participation in another interventional clinical trial or use of investigational drugs or devices within 30 days prior to Visit 1
  • Previous enrollment in Study ALKS 2680-201
  • Currently pregnant, breastfeeding, or planning pregnancy during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

Alkermes Investigational Site

Brandon, Florida, United States, 33511

Actively Recruiting

2

Alkermes Investigational Site

Macon, Georgia, United States, 31210

Actively Recruiting

3

Alkermes Investigational Site

Lansing, Michigan, United States, 48911

Actively Recruiting

4

Alkermes Investigational Site

St Louis, Missouri, United States, 63123

Actively Recruiting

5

Alkermes Investigational Site

Cincinnati, Ohio, United States, 45245

Actively Recruiting

6

Alkermes Investigational Site

Wyomissing, Pennsylvania, United States, 19610

Actively Recruiting

7

Alkermes Investigational Site

Columbia, South Carolina, United States, 29201

Actively Recruiting

8

Alkermes Investigational Site

Austin, Texas, United States, 78731

Actively Recruiting

9

Alkermes Investigational Site

Sugar Land, Texas, United States, 77478

Actively Recruiting

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Research Team

D

Director, Clinical Trial Manager

CONTACT

D

Director, Clinical Trial Manager

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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