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NCT Number: NCT06767683

A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia

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.

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Key information

Conditions

Narcolepsy Type 1 Disorders of Excessive Somnolence Dyssomnias Idiopathic Hypersomnia Mental Disorders Narcolepsy Narcolepsy Type 2 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 / Phase 3

Primary location

Alkermes Investigational Site, Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ALKS 2680, 4mg

Drug

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

ALKS 2680, 6mg

Drug

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

ALKS 2680, 8mg

Drug

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

ALKS 2680, 10mg

Drug

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

ALKS 2680, 14mg

Drug

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

ALKS 2680, 18mg

Drug

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

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: Up to 100 Weeks

Secondary outcomes

  1. Change in the mean sleep latency (MSL) on Maintenance of Wakefulness Test (MWT)

    Time frame: Baseline to Week 24

  2. Change in Epworth Sleepiness Scale (ESS)

    Time frame: Baseline to 96 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

An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Subjects With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 10, 2025
Registry last updated
Mar 4, 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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