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A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial sites expanded: 17 → 20 locations Secondary endpoints: details revised at 2 of 9 entries · Eligibility criteria expanded, about 5 words Show 2 more changesShow less
    • Secondary endpoints: details revised at 2 of 9 entries
    • Eligibility criteria expanded, about 5 words
  2. Minor Trial sites expanded: 14 → 17 locations Start date changed from estimate of Aug 2026 to Aug 13, 2026v8 Show 1 more changeShow less
    • Start date changed from estimate of Aug 2026 to Aug 13, 2026
  3. Notable Start date: Jun 2026 to Aug 2026 Trial sites expanded: 10 → 14 locationsv7 Show 1 more changeShow less
    • Trial sites expanded: 10 → 14 locations
  4. Minor Trial sites expanded: 5 → 10 locationsv6
  5. Minor Re-verified, no change to tracked fieldsv5
  6. Minor Trial sites expanded: 1 → 5 locations Start date: May 2026 to Jun 2026v4 Show 1 more changeShow less
    • Start date: May 2026 to Jun 2026
  7. Minor Study Status, Referencesv3
  8. Notable Recruitment opened Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  9. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 decreases in daytime sleepiness, cataplexy (sudden loss of muscle tone), and disease symptoms in participants with NT1 when taking ALKS 2680 tablets compared with placebo tablets.
Trial Details
NCT Number NCT07540897
Lead Sponsor Alkermes, Inc.
Conditions Narcolepsy Type 1
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov