Recruiting
Phase 2
Phase 3

ALKS 2680

Sponsor:

Alkermes, Inc.

Code:

NCT06767683

Conditions

Narcolepsy Type 1

Narcolepsy Type 2

Idiopathic Hypersomnia

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

ALKS 2680, 4mg

ALKS 2680, 6mg

ALKS 2680, 8mg

ALKS 2680, 10mg

ALKS 2680, 14mg

Study Details

Brief summary:

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

Study ID

NCT06767683

Start date

Jan 27, 2025

Status verified date

Aug, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Enrollment

256 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Narcolepsy Type 1 (NT1)

experimental: Narcolepsy Type 2 (NT2)

experimental: Idiopathic Hypersomnia (IH)

Interventions

ALKS 2680, 4mg

Oral tablet containing 4 mg of ALKS 2680 for once daily administration

ALKS 2680, 6mg

Oral tablet containing 6 mg of ALKS 2680 for once daily administration

ALKS 2680, 8mg

Oral tablet containing 8 mg of ALKS 2680 for once daily administration

ALKS 2680, 10mg

Oral tablet containing 10 mg of ALKS 2680 for once daily administration

ALKS 2680, 14mg

Oral tablet containing 14 mg of ALKS 2680 for once daily administration

ALKS 2680, 18mg

Oral tablet containing 18 mg of ALKS 2680 for once daily administration

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: Up to 100 Weeks ]

Central Contacts and Locations

Central contacts

Director, Global Clinical Services

888-235-8008 (US Only)clinicaltrials@alkermes.com

Director, Global Clinical Services

571-599-2702 (Global)clinicaltrials@alkermes.com

Locations

Alkermes Investigational Site

Recruiting

Cullman, Alabama, United States, 35055

Alkermes Investigator Site

Recruiting

Phoenix, Arizona, United States, 85054

Alkermes Investigational Site

Recruiting

Little Rock, Arkansas, United States, 72211

Alkermes Investigational Site

Recruiting

Los Angeles, California, United States, 90025

Alkermes Investigator Site

Recruiting

San Francisco, California, United States, 94158

Alkermes Investigational Site

Recruiting

Stanford, California, United States, 94305

Alkermes Investigational Site

Recruiting

Boulder, Colorado, United States, 80309

Alkermes Investigational Site

Recruiting

Colorado Springs, Colorado, United States, 80918

Alkermes Investigational Site

Recruiting

Brandon, Florida, United States, 33511

Alkermes Investigational Site

Recruiting

Miami, Florida, United States, 33176

Alkermes Investigational Site

Recruiting

Winter Park, Florida, United States, 32789

Alkermes Investigational Site

Recruiting

Atlanta, Georgia, United States, 30328

Alkermes Investigational Site

Recruiting

Macon, Georgia, United States, 31210

Alkermes Investigational Site

Recruiting

Stockbridge, Georgia, United States, 30281

Alkermes Investigational Site

Recruiting

Peoria, Illinois, United States, 61637

Alkermes Investigational Site

Recruiting

Kansas City, Kansas, United States, 66160

Alkermes Investigational Site

Recruiting

Lansing, Michigan, United States, 48911

Alkermes Investigational Site

Recruiting

Sterling Heights, Michigan, United States, 48314

Alkermes Investigational Site

Recruiting

Lincoln, Nebraska, United States, 68506

Alkermes Investigational Site

Recruiting

Middletown, New Jersey, United States, 07748

Alkermes Investigational Site

Recruiting

Denver, North Carolina, United States, 28037

Alkermes Investigational Site

Recruiting

Huntersville, North Carolina, United States, 28708

Alkermes Investigational Site

Recruiting

Canton, Ohio, United States, 44718

Alkermes Investigational Site

Recruiting

Cincinnati, Ohio, United States, 45212

Alkermes Investigational Site

Recruiting

Cincinnati, Ohio, United States, 45245

Alkermes Investigational Site

Recruiting

Dublin, Ohio, United States, 43017

Alkermes Investigational Site

Recruiting

Abington, Pennsylvania, United States, 19001

Alkermes Investigational Site

Recruiting

Wyomissing, Pennsylvania, United States, 19610

Alkermes Investigational Site

Recruiting

Columbia, South Carolina, United States, 29201

Alkermes Investigational Site

Recruiting

Austin, Texas, United States, 78731

Alkermes Investigational Site

Recruiting

San Antonio, Texas, United States, 78229

Alkermes Investigational Site

Recruiting

Sugar Land, Texas, United States, 77478

Alkermes Investigational Site

Recruiting

Madison, Wisconsin, United States, 53706

More Information

Sponsor

Alkermes, Inc.

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Keywords

  • Narcolepsy
  • Narcolepsy Type 1
  • Narcolepsy Type 2
  • NT1
  • NT2
  • orexin-2 receptor agonist
  • sleep
  • sleep disorder
  • excessive daytime sleepiness
  • IH
  • Idiopathic Hypersomnia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Alkermes, Inc. on 2026-08-07.