Recruiting

Phase 2

ALKS 2680A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia

Sponsor:

Alkermes, Inc.

Code:

NCT06843590

Conditions

Idiopathic Hypersomnia

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

ALKS 2680

Placebo

Study Details

Brief summary:

The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets

Conditions

Idiopathic Hypersomnia

Study ID

NCT06843590

Start date

May 22, 2025

Status verified date

Jun, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits.
Meets the diagnostic criteria of Idiopathic Hypersomnia according to ICSD-3-TR guidelines, confirmed by the diagnostic evaluations (PSG/MSLT/actigraphy) within the previous 10 years

Exclusion Criteria:

Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle
Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject's ability to complete the study
Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1
Is currently pregnant, breastfeeding, or is planning to become pregnant during the study

Study Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ALKS 2680, 10 mg- Part A

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

experimental: ALKS 2680, 14 mg -Part A

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

experimental: ALKS 2680, 18 mg- Part A

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

placebo comparator: Placebo- Part A

Oral placebo tablet for once daily administration

experimental: ALKS 2680 Dose 1- Part B

Oral tablets of ALKS 2680 taken, orally, daily

placebo comparator: Placebo - Part B

Oral tablets of placebo taken, orally, daily

Interventions

ALKS 2680

Oral tablet containing ALKS 2680 for daily, oral administration

Placebo

Oral placebo tablet for daily administration

Primary outcome measure

Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level [ Time Frame: Up to 8 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 Investigator Site

Recruiting

Cullman, Alabama, United States, 35055

Alkermes Investigator Site

Recruiting

Phoenix, Arizona, United States, 85054

Alkermes Investigator Site

Recruiting

Little Rock, Arkansas, United States, 72211

Alkermes Investigator Site

Recruiting

Los Angeles, California, United States, 90025

Alkermes Investigator Site

Recruiting

Redwood City, California, United States, 94063

Alkermes Investigator Site

Recruiting

San Francisco, California, United States, 94143

Alkermes Investigational Site

Recruiting

Boulder, Colorado, United States, 80301

Alkermes Investigator Site

Recruiting

Colorado Springs, Colorado, United States, 80918

Alkermes Investigator Site

Recruiting

Brandon, Florida, United States, 33511

Alkermes Investigator Site

Recruiting

Miami, Florida, United States, 33176

Alkermes Investigator Site

Recruiting

Winter Park, Florida, United States, 32789

Alkermes Investigator Site

Recruiting

Atlanta, Georgia, United States, 30328

Alkermes Investigator Site

Recruiting

Macon, Georgia, United States, 31210

Alkermes Investigator Site

Recruiting

Stockbridge, Georgia, United States, 30281

Alkermes Investigator Site

Recruiting

Peoria, Illinois, United States, 61637

Alkermes Investigator Site

Recruiting

Kansas City, Kansas, United States, 66160

Alkermes Investigational Site

Recruiting

Boston, Massachusetts, United States, 02215

Alkermes Investigator Site

Recruiting

Lansing, Michigan, United States, 48911

Alkermes Investigator Site

Recruiting

Lincoln, Nebraska, United States, 68506

Alkermes Investigator Site

Recruiting

Middletown, New Jersey, United States, 07748

Alkermes Investigator Site

Recruiting

Denver, North Carolina, United States, 28037

Alkermes Investigator Site

Recruiting

Huntersville, North Carolina, United States, 28078

Alkermes Investigator Site

Recruiting

Canton, Ohio, United States, 44718

Alkermes Investigator Site

Recruiting

Cincinnati, Ohio, United States, 45245

Alkermes Investigator Site

Recruiting

Cleveland, Ohio, United States, 44195

Alkermes Investigator Site

Recruiting

Danville, Pennsylvania, United States, 17822

Alkermes Investigator Site

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Alkermes Investigator Site

Recruiting

Wyomissing, Pennsylvania, United States, 19610

Alkermes Investigator Site

Recruiting

Columbia, South Carolina, United States, 29201

Alkermes Investigator Site

Recruiting

Austin, Texas, United States, 78731

Alkermes Investigator Site

Recruiting

San Antonio, Texas, United States, 78229

Alkermes Investigator Site

Recruiting

Sugar Land, Texas, United States, 77478

Alkermes Investigator Site

Recruiting

Sugarland, Texas, United States, 77478

Alkermes Investigator Site

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

Alkermes, Inc.

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Keywords

Idiopathic Hypersomnia
IH
sleep
sleep disorder
orexin-2 receptor agonist
excessive daytime sleepiness

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 2026-06-24.