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

NCT06843590 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ALKS 2680-203
• Study Type: interventional
• Target: 96
• Locations: 8 countries
• Sites: 48

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level

  Up to 8 weeks

Secondary Outcomes (1)

• Change in Idiopathic Hypersomnia Severity Scale (IHSS) from baseline to Week 8 by dose level

  Up to 8 weeks

Study Arms (4)

ALKS 2680, 10 mg

EXPERIMENTAL

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

Drug: ALKS 2680

ALKS 2680, 14 mg

EXPERIMENTAL

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

Drug: ALKS 2680

ALKS 2680, 18 mg

EXPERIMENTAL

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

Drug: ALKS 2680

Placebo

PLACEBO COMPARATOR

Oral placebo tablet for once daily administration

Drug: Placebo

Interventions

ALKS 2680 DRUG

Oral tablet containing ALKS 2680 for once daily administration

ALKS 2680, 10 mg; ALKS 2680, 14 mg; ALKS 2680, 18 mg

Placebo DRUG

Oral placebo tablet for once daily administration

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alkermes, Inc.: lead

Study Sites (48)

Alkermes Investigator Site

Cullman, Alabama, 35055, United States

RECRUITING

Alkermes Investigator Site

Phoenix, Arizona, 85054, United States

RECRUITING

Alkermes Investigator Site

Little Rock, Arkansas, 72211, United States

RECRUITING

Alkermes Investigator Site

Los Angeles, California, 90025, United States

RECRUITING

Alkermes Investigator Site

Redwood City, California, 94063, United States

RECRUITING

Alkermes Investigator Site

San Francisco, California, 94143, United States

RECRUITING

Alkermes Investigator Site

Colorado Springs, Colorado, 80918, United States

RECRUITING

Alkermes Investigator Site

Brandon, Florida, 33511, United States

RECRUITING

Alkermes Investigator Site

Miami, Florida, 33176, United States

RECRUITING

Alkermes Investigator Site

Winter Park, Florida, 32789, United States

RECRUITING

Alkermes Investigator Site

Atlanta, Georgia, 30328, United States

RECRUITING

Alkermes Investigator Site

Macon, Georgia, 31210, United States

RECRUITING

Alkermes Investigator Site

Stockbridge, Georgia, 30281, United States

RECRUITING

Alkermes Investigator Site

Peoria, Illinois, 61637, United States

RECRUITING

Alkermes Investigator Site

Kansas City, Kansas, 66160, United States

RECRUITING

Alkermes Investigator Site

Lansing, Michigan, 48911, United States

RECRUITING

Alkermes Investigator Site

Lincoln, Nebraska, 68506, United States

RECRUITING

Alkermes Investigator Site

Middletown, New Jersey, 07748, United States

RECRUITING

Alkermes Investigator Site

Denver, North Carolina, 28037, United States

RECRUITING

Alkermes Investigator Site

Huntersville, North Carolina, 28078, United States

RECRUITING

Alkermes Investigator Site

Canton, Ohio, 44718, United States

RECRUITING

Alkermes Investigator Site

Cincinnati, Ohio, 45245, United States

RECRUITING

Alkermes Investigator Site

Cleveland, Ohio, 44195, United States

RECRUITING

Alkermes Investigator Site

Danville, Pennsylvania, 17822, United States

RECRUITING

Alkermes Investigator Site

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Alkermes Investigator Site

Wyomissing, Pennsylvania, 19610, United States

RECRUITING

Alkermes Investigator Site

Columbia, South Carolina, 29201, United States

RECRUITING

Alkermes Investigator Site

Austin, Texas, 78731, United States

RECRUITING

Alkermes Investigator Site

San Antonio, Texas, 78229, United States

RECRUITING

Alkermes Investigator Site

Sugar Land, Texas, 77478, United States

RECRUITING

Alkermes Investigator Site

Sugarland, Texas, 77478, United States

RECRUITING

Alkermes Investigator Site

Madison, Wisconsin, 53792, United States

RECRUITING

Alkermes Investigator Site

Sydney, New South Wales, 2113, Australia

RECRUITING

Alkermes Investigator Site

Bedford Park, South Australia, 5042, Australia

RECRUITING

Alkermes Investigator Site

Clayton, Victoria, 3168, Australia

RECRUITING

Alkermes Investigator Site

Alken, 3570, Belgium

RECRUITING

Alkermes Investigator Site

Namur, 5101, Belgium

RECRUITING

Alkermes Investigator Site

Prague, 128 21, Czechia

RECRUITING

Alkermes Investigator Site

Bordeaux, Gironde, 33000, France

RECRUITING

Alkermes Investigator Site

Montpellier, Herault, 34295, France

RECRUITING

Alkermes Investigator Site

Grenoble, Isere, 38043, France

RECRUITING

Alkermes Investigator Site

Bologna, 40139, Italy

RECRUITING

Alkermes Investigator Site

Milan, 20127, Italy

RECRUITING

Alkermes Investigator Site

Verona, 37134, Italy

RECRUITING

Alkermes Investigator Site

Zwolle, 8025 BV, Netherlands

RECRUITING

Alkermes Investigator Site

Barcelona, 8036, Spain

RECRUITING

Alkermes Investigator Site

Madrid, 28036, Spain

RECRUITING

Alkermes Investigator Site

Madrid, 28043, Spain

RECRUITING

MeSH Terms

Conditions

Idiopathic Hypersomnia; Sleep Wake Disorders; Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Alkermes, Inc.

  STUDY DIRECTOR

Central Study Contacts

Director, Global Clinical Services

CONTACT

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

Director, Global Clinical Services

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 25, 2025
• Study Start: May 22, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

FR (3); NL (1); BE (2); IT (3); CZ (1); ES (3); AU (3); US (32)