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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) or Narcolepsy Type 2 (NT2) when taking ALKS 2680 tablets

Conditions

Narcolepsy Type 1
Narcolepsy Type 2
Idiopathic Hypersomnia

Eligibility

Eligible Ages: Between 18 Years and 70 Years
Eligible Genders: 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

Arm	Description	Assigned 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
Brandon, Florida 33511

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
Denver, North Carolina 28037

Alkermes Investigational Site
Huntersville, North Carolina 28708

Alkermes Investigational Site
Cincinnati, Ohio 45212

Alkermes Investigational Site
Cincinnati, Ohio 45245

Alkermes Investigational Site
Dublin, Ohio 43017

Alkermes Investigational Site
Columbia, South Carolina 29201

Alkermes Investigational Site
San Antonio, Texas 78229

More Details

NCT ID: NCT06767683
Status: Recruiting
Sponsor: Alkermes, Inc.

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.