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 4119403, Arkansas 4099753 72211

Alkermes Investigational Site
Los Angeles 5368361, California 5332921 90025

Alkermes Investigational Site
Stanford 5398563, California 5332921 94305

Alkermes Investigational Site
Colorado Springs 5417598, Colorado 5417618 80918

Alkermes Investigational Site
Brandon 4148757, Florida 4155751 33511

Alkermes Investigational Site
Miami 4164138, Florida 4155751 33176

Alkermes Investigational Site
Winter Park 4178560, Florida 4155751 32789

Alkermes Investigational Site
Atlanta 4180439, Georgia 4197000 30328

Alkermes Investigational Site
Macon 4207400, Georgia 4197000 31210

Alkermes Investigational Site
Stockbridge 4224681, Georgia 4197000 30281

Alkermes Investigational Site
Peoria 4905687, Illinois 4896861 61637

Alkermes Investigational Site
Lansing 4998830, Michigan 5001836 48911

Alkermes Investigational Site
Sterling Heights 5011148, Michigan 5001836 48314

Alkermes Investigational Site
Lincoln 5072006, Nebraska 5073708 68506

Alkermes Investigational Site
Middletown 5101170, New Jersey 5101760 07748

Alkermes Investigational Site
Denver 4463523, North Carolina 4482348 28037

Alkermes Investigational Site
Huntersville 4472370, North Carolina 4482348 28708

Alkermes Investigational Site
Canton 5149222, Ohio 5165418 44718

Alkermes Investigational Site
Cincinnati 4508722, Ohio 5165418 45212

Alkermes Investigational Site
Cincinnati 4508722, Ohio 5165418 45245

Alkermes Investigational Site
Dublin 5152333, Ohio 5165418 43017

Alkermes Investigational Site
Abington 5177773, Pennsylvania 6254927 19001

Alkermes Investigational Site
Wyomissing 5220248, Pennsylvania 6254927 19610

Alkermes Investigational Site
Columbia 4575352, South Carolina 4597040 29201

Alkermes Investigational Site
Austin 4671654, Texas 4736286 78731

Alkermes Investigational Site
San Antonio 4726206, Texas 4736286 78229

Alkermes Investigational Site
Sugar Land 4734825, Texas 4736286 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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Vanderbilt University Medical Center