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A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

Study acronym: Brilliance NT1
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study sites: 42 to 44 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: 29 → 42 locationsv9
  3. Minor Trial sites expanded: 22 → 29 locationsv8
  4. Minor Trial sites expanded: 17 → 22 locationsv7
  5. Minor Trial sites expanded: 9 → 17 locationsv6
  6. Minor Study Status, Referencesv5
  7. Minor Trial sites expanded: 3 → 9 locationsv4
  8. Notable Recruitment opened Trial sites expanded: 0 → 3 locations · Start date changed from estimate of Mar 2026 to Apr 6, 2026v3 Show 2 more changesShow less
    • Trial sites expanded: 0 → 3 locations
    • Start date changed from estimate of Mar 2026 to Apr 6, 2026
  9. Minor Re-verified, no change to tracked fieldsv2
  10. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 NCT07455383
Lead Sponsor Alkermes, Inc.
Conditions Narcolepsy Type 1
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov