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NCT Number: NCT06843590

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

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

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Key information

Conditions

Idiopathic Hypersomnia Disorders of Excessive Somnolence Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alkermes Investigator Site, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALKS 2680

Drug

Oral tablet containing ALKS 2680 for daily, oral administration

Placebo

Drug

Oral placebo tablet for daily administration

Primary outcomes

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

    Time frame: Up to 8 weeks

Secondary outcomes

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

    Time frame: Up to 8 weeks

  2. Incidence of treatment emergent adverse events

    Time frame: Up to 10 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Director, Global Clinical Services

CONTACT

[email protected]

888-235-8008 (US Only)

Director, Global Clinical Services

CONTACT

[email protected]

571-599-2702 (Global)

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

A Phase 2, Randomized, Parallel-Group, Double-Blind, Dose-Range-Finding Study to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Idiopathic Hypersomnia (Vibrance-3)

Acronym: Vibrance-3

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2025
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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