A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia

Purpose

The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.

Conditions

  • Narcolepsy Type 1
  • Narcolepsy Type 2
  • Idiopathic Hypersomnia

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Was eligible for and has completed end of treatment visit of ALKS 2680 eligible parent study in NT1, NT2 or IH. The current eligible studies are ALKS 2680-201 (Vibrance-1), ALKS 2680-202 (Vibrance-2) and ALKS 2680-203 (Vibrance-3) - Is willing and able, and in the opinion of the treating physician can safely discontinue any medications prescribed for the management of narcolepsy symptoms, as applicable, for 5 half-lives prior to Day 1 (for re-entry subjects), and for the duration of study (for all subjects)

Exclusion Criteria

  • Developed a new clinically significant health condition, ECG or laboratory abnormality, in the opinion of the Investigator or Sponsor, may impact the subject's participation in the study - Is currently pregnant, breastfeeding, or planning to become pregnant during the study - 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

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Narcolepsy Type 1 (NT1)
  • Drug: ALKS 2680, 4mg
    Oral tablet containing 4 mg of ALKS 2680 for once daily administration
  • Drug: ALKS 2680, 6mg
    Oral tablet containing 6 mg of ALKS 2680 for once daily administration
  • Drug: ALKS 2680, 8mg
    Oral tablet containing 8 mg of ALKS 2680 for once daily administration
Experimental
Narcolepsy Type 2 (NT2)
  • Drug: ALKS 2680, 10mg
    Oral tablet containing 10 mg of ALKS 2680 for once daily administration
  • Drug: ALKS 2680, 14mg
    Oral tablet containing 14 mg of ALKS 2680 for once daily administration
  • Drug: ALKS 2680, 18mg
    Oral tablet containing 18 mg of ALKS 2680 for once daily administration
Experimental
Idiopathic Hypersomnia (IH)
  • Drug: ALKS 2680, 10mg
    Oral tablet containing 10 mg of ALKS 2680 for once daily administration
  • Drug: ALKS 2680, 14mg
    Oral tablet containing 14 mg of ALKS 2680 for once daily administration
  • Drug: ALKS 2680, 18mg
    Oral tablet containing 18 mg of ALKS 2680 for once daily administration

Recruiting Locations

Alkermes Investigational Site
Little Rock, Arkansas 72211

Alkermes Investigational Site
Los Angeles, California 90025

Alkermes Investigational Site
Stanford, California 94305

Alkermes Investigational Site
Colorado Springs, Colorado 80918

Alkermes Investigational Site
Brandon, Florida 33511

Alkermes Investigational Site
Miami, Florida 33176

Alkermes Investigational Site
Winter Park, Florida 32789

Alkermes Investigational Site
Atlanta, Georgia 30328

Alkermes Investigational Site
Macon, Georgia 31210

Alkermes Investigational Site
Stockbridge, Georgia 30281

Alkermes Investigational Site
Peoria, Illinois 61637

Alkermes Investigational Site
Lansing, Michigan 48911

Alkermes Investigational Site
Sterling Heights, Michigan 48314

Alkermes Investigational Site
Lincoln, Nebraska 68506

Alkermes Investigational Site
Middletown, New Jersey 07748

Alkermes Investigational Site
Denver, North Carolina 28037

Alkermes Investigational Site
Huntersville, North Carolina 28708

Alkermes Investigational Site
Canton, Ohio 44718

Alkermes Investigational Site
Cincinnati, Ohio 45212

Alkermes Investigational Site
Cincinnati, Ohio 45245

Alkermes Investigational Site
Dublin, Ohio 43017

Alkermes Investigational Site
Abington, Pennsylvania 19001

Alkermes Investigational Site
Wyomissing, Pennsylvania 19610

Alkermes Investigational Site
Columbia, South Carolina 29201

Alkermes Investigational Site
Austin, Texas 78731

Alkermes Investigational Site
San Antonio, Texas 78229

Alkermes Investigational Site
Sugar Land, Texas 77478

More Details

NCT ID
NCT06767683
Status
Recruiting
Sponsor
Alkermes, Inc.

Study Contact

Director, Global Clinical Services
888-235-8008 (US Only)
clinicaltrials@alkermes.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center