ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-07-26
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06555783

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18-70 years of age
  2. * Has a BMI ≥18 and ≤40 kg/m2
  3. * Meets the diagnostic criteria of Narcolepsy type 2 according to ICSD-3-TR guidelines.
  4. * Has residual excessive daytime sleepiness
  5. * 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
  6. * Is willing to adhere to additional protocol requirements
  1. * 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
  2. * Is currently pregnant, breastfeeding, or planning to become pregnant during the study
  3. * Is currently enrolled in another clinical study (other than the parent study) or used any investigational drug or device within 30 days prior to Screening

Contacts and Locations

Principal Investigator

Medical Director, MD
STUDY_DIRECTOR
Alkermes, Inc.

Study Locations (Sites)

Alkermes Investigator Site
Little Rock, Arkansas, 72211
United States
Alkermes Investigator Site
Los Angeles, California, 90025
United States
Alkermes Investigator Site
Redwood City, California, 94063
United States
Alkermes Investigator Site
San Francisco, California, 94143
United States
Alkermes Investigator Site
Santa Ana, California, 92705
United States
Alkermes Investigational Site
Aurora, Colorado, 80045
United States
Alkermes Investigator Site
Colorado Springs, Colorado, 80918
United States
Alkermes Investigator Site
Brandon, Florida, 33511
United States
Alkermes Investigator Site
Miami, Florida, 33176
United States
Alkermes Investigator Site
Winter Park, Florida, 32789
United States
Alkermes Investigator Site
Atlanta, Georgia, 30328
United States
Alkermes Investigational Site
Macon, Georgia, 31210
United States
Alkermes Investigator Site
Stockbridge, Georgia, 30281
United States
Alkermes Investigational Site
Peoria, Illinois, 61637
United States
Alkermes Investigator Site
Lansing, Michigan, 48911
United States
Alkermes Investigator Site
Sterling Heights, Michigan, 48314
United States
Alkermes Investigator Site
Lincoln, Nebraska, 68506
United States
Alkermes Investigator Site
Middletown, New Jersey, 07748
United States
Alkermes Investigator Site
Denver, North Carolina, 28037
United States
Alkermes Investigator Site
Huntersville, North Carolina, 28078
United States
Alkermes Investigator Site
Canton, Ohio, 44718
United States
Alkermes Investigator Site
Cincinnati, Ohio, 45212
United States
Alkermes Investigator Site
Cincinnati, Ohio, 45245
United States
Alkermes Investigational Site
Cleveland, Ohio, 44195
United States
Alkermes Investigator Site
Abington, Pennsylvania, 19001
United States
Alkermes Investigational Site
Philadelphia, Pennsylvania, 19107
United States
Alkermes Investigator Site
Wyomissing, Pennsylvania, 19610
United States
Alkermes Investigator Site
Columbia, South Carolina, 29201
United States
Alkermes Investigator Site
Austin, Texas, 78731
United States
Alkermes Investigator Site
San Antonio, Texas, 78229
United States
Alkermes Investigational Site
Sugar Land, Texas, 77478
United States
Alkermes Investigator Site
Sugarland, Texas, 77478
United States
Alkermes Investigational Site
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Alkermes, Inc.

  • Medical Director, MD, STUDY_DIRECTOR, Alkermes, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-26
Study Completion Date2025-11

Study Record Updates

Study Start Date2024-07-26
Study Completion Date2025-11

Terms related to this study

Keywords Provided by Researchers

  • Narcolepsy
  • Narcolepsy Type 2
  • NT2
  • Orexin-2 receptor agonist
  • Sleep
  • Sleep disorder
  • Excessive daytime sleepiness

Additional Relevant MeSH Terms

  • Narcolepsy Type 2