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OpenTrials
Completed

NCT Number: NCT06555783

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2

The purpose of this study is to measure the safety and decrease in sleepiness in subjects with narcolepsy type 2 (NT2) when taking ALKS 2680 tablets compared to placebo tablets.

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Key information

Conditions

Narcolepsy Type 2 Disorders of Excessive Somnolence Dyssomnias Mental Disorders Narcolepsy 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, Macquarie Park, 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

  • 18-70 years of age
  • Has a BMI ≥18 and ≤40 kg/m2
  • Meets the diagnostic criteria of Narcolepsy type 2 according to ICSD-3-TR guidelines.

Additionally, meets the following criteria:

  • Has residual excessive daytime sleepiness
  • Is willing and able to discontinue any medications prescribed for the management of narcolepsy symptoms for at least 14 days and for the duration of study
  • Is willing to adhere to additional protocol requirements

Exclusion criteria

  • Significant comorbid medical conditions, including other sleep, cardiovascular, psychiatric, hepatic or other disorders may be exclusionary; eligibility will be determined on an individual basis by the study investigator
  • 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

Drug

Oral tablet containing ALKS 2680

Placebo

Drug

Oral tablet containing placebo for once daily administration

Primary outcomes

  1. Change in Mean Sleep Latency (MSL) on the Maintenance Wakefulness Test (MWT)

    Time frame: Baseline to Week 8

  2. Change in Epworth Sleepiness Scale (ESS)

    Time frame: Baseline to week 8

    Participants will be asked to complete the ESS, reporting on the level of sleepiness they experienced over the past 7 days.

Secondary outcomes

  1. Incidence of adverse events

    Time frame: Up to 21 weeks

Sponsors and collaborators

Lead sponsor

Alkermes, Inc.

Industry

Registry information

Official study title

A Phase 2, Parallel-Group, Dose-Range-Finding Study With Randomized Double-Blind Treatment and Open-Label Periods to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Narcolepsy Type 2

Acronym: Vibrance-2

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2024
Registry last updated
Feb 27, 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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