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

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Jun 2028 → Jun 2030
See other at-risk trials from Alkermes

Record History

  1. Primary and study completion pushed from Jun 2028 to Jun 2030 Enrollment increased: 256 → 786 participants · Study sites: 49 to 50 · Eligibility criteria expanded, about 20 words · 1 more Show 4 more changesShow less
    • Enrollment increased: 256 → 786 participants
    • Study sites: 49 to 50
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: 2 to 4
  2. Trial sites expanded: 46 → 49 locationsv9
  3. Study sites: 44 to 46v8
  4. Study sites: 42 to 44v7
  5. Study sites: 41 to 42v6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary and study completion dates: Nov 2027 to Jun 2028 Study sites: 27 to 41v5 Show 1 more changeShow less
    • Study sites: 27 to 41
  2. Study sites: 12 to 27v4
  3. Re-verified, no change to tracked fieldsv3
  4. Enrollment target: 160 to 256 Study sites: 5 to 12 · Start date changed from estimate of Jan 2025 to Jan 27, 2025 · Study arms: 2 to 3 · 2 morev2 Show 5 more changesShow less
    • Study sites: 5 to 12
    • Start date changed from estimate of Jan 2025 to Jan 27, 2025
    • Study arms: 2 to 3
    • Eligibility criteria expanded, about 4 words
    • Study title expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Alkermes
10 trials monitored
See 1 trial at risk
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.
Trial Details
NCT Number NCT06767683
Lead Sponsor Alkermes, Inc.
Conditions Narcolepsy Type 1, Narcolepsy Type 2, Idiopathic Hypersomnia
Enrollment 786 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov