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

Study acronym: Vibrance-3
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Enrollment closed, study ongoing Eligibility criteria expanded, about 6 words · Site details revised at 50 of 50 sites Show 2 more changesShow less
    • Eligibility criteria expanded, about 6 words
    • Site details revised at 50 of 50 sites
  2. Minor Primary and study completion pushed from Jun 2026 to Nov 2026 Enrollment increased: 96 → 126 participants · Trial arms changed: 4 → 6 · Study sites: 48 to 50 · 1 morev10 Show 4 more changesShow less
    • Enrollment increased: 96 → 126 participants
    • Trial arms changed: 4 → 6
    • Study sites: 48 to 50
    • Secondary endpoints: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Study sites: 40 to 48v9
  4. Minor Study sites: 31 to 40v8
  5. Minor Study sites: 19 to 31v7
Show 5 earlier versionsHide 5 earlier versions
  1. Minor Study sites: 8 to 19 Primary completion date: Apr 2026 to Jun 2026v6 Show 1 more changeShow less
    • Primary completion date: Apr 2026 to Jun 2026
  2. Notable Start date: Apr 21, 2025 to May 22, 2025v5
  3. Minor Study sites: 2 to 8v4
  4. Minor Start date changed from estimate of Apr 2025 to Apr 21, 2025v3
  5. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2v2 Show 1 more changeShow less
    • Study sites: 0 to 2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
10 trials monitored
See 1 trial at risk
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
Trial Details
NCT Number NCT06843590
Lead Sponsor Alkermes, Inc.
Conditions Idiopathic Hypersomnia
Enrollment 126 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov