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Completed

NCT Number: NCT06358950

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)

The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone.

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Key information

Conditions

Narcolepsy Type 1 Cataplexy Disorders of Excessive Somnolence Dyssomnias Mental Disorders Narcolepsy Nervous System Diseases 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

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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 1 according to ICSD-3-TR guidelines. Additionally, meets the following criteria:
  • Is HLA-DQB1*06:02-positive
  • Has residual excessive daytime sleepiness and cataplexy
  • 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 of ALKS 2680 for once daily administration

Placebo

Drug

Oral tablet containing matching placebo for once daily administration

Primary outcomes

  1. Change in Mean Sleep Latency (MSL) on the Maintenance of Wakefulness Test (MWT) from baseline to Week 6

    Time frame: Baseline to Week 6

Secondary outcomes

  1. Change in Epworth Sleepiness Scale (ESS) from baseline to Week 6

    Time frame: Baseline to Week 6

    Epsworth Sleepiness Scale is a 4-point scale used to measure excessive sleepiness from 0 (would never doze) to 3 (high chance of "dozing)

  2. Mean weekly cataplexy rate (WCR) as derived by subject cataplexy diary

    Time frame: Measured at Week 5 and 6

  3. Incidence of adverse events

    Time frame: Up to 15 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 1

Acronym: Vibrance-1

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 11, 2024
Registry last updated
Jun 10, 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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