A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2

Description

The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.

Conditions

Narcolepsy Type 2

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Study Overview

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Study Details

Study overview

The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.

A Phase 2, Parallel-Group, Dose-Range-Finding Study With Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Narcolepsy Type 2

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2

Condition
Narcolepsy Type 2
Intervention / Treatment

-

Contacts and Locations

Little Rock

Alkermes Investigator Site, Little Rock, Arkansas, United States, 72211

Los Angeles

Alkermes Investigator Site, Los Angeles, California, United States, 90025

Santa Ana

Alkermes Investigator Site, Santa Ana, California, United States, 92705

Colorado Springs

Alkermes Investigator Site, Colorado Springs, Colorado, United States, 80918

Brandon

Alkermes Investigator Site, Brandon, Florida, United States, 33511

Miami

Alkermes Investigator Site, Miami, Florida, United States, 33176

Winter Park

Alkermes Investigator Site, Winter Park, Florida, United States, 32789

Atlanta

Alkermes Investigator Site, Atlanta, Georgia, United States, 30328

Macon

Alkermes Investigational Site, Macon, Georgia, United States, 31210

Stockbridge

Alkermes Investigator Site, Stockbridge, Georgia, United States, 30281

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 18-70 years of age
  • * Has a BMI ≥18 and ≤40 kg/m2
  • * Meets the diagnostic criteria of Narcolepsy type 2 according to ICSD-3-TR guidelines.
  • * Has residual excessive daytime sleepiness
  • * Is willing and able to discontinue any medications prescribed for the management of narcolepsy symptoms for at least 14 days and for the duration of study
  • * Is willing to adhere to additional protocol requirements
  • * Significant comorbid medical conditions, including other sleep, cardiovascular, psychiatric, hepatic or other disorders may be exclusionary; eligibility will be determined on an individual basis by the study investigator

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alkermes, Inc.,

Medical Director, MD, STUDY_DIRECTOR, Alkermes, Inc.

Study Record Dates

2025-09