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Masupirdine for the Treatment of Agitation in Dementia of the Alzheimer's Type

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised at 44 of 44 sites
  2. Primary and study completion dates: Dec 2025 to Dec 2026
    • Study sites: 52 to 44
    v10
  3. Primary and study completion dates: Jan 2025 to Dec 2025v9
  4. Study sites: 44 to 52v8
  5. Study sites: 47 to 44v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 31 to 47v6
  2. Study sites: 21 to 31v5
  3. Study sites: 5 to 21
    • Start date changed from estimate of Sep 2022 to Nov 1, 2022
    v4
  4. Start date: Jun 2022 to Sep 2022
    • Study sites: 2 to 5
    v3
  5. Secondary endpoints: details revised at 1 of 1 entryv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study will be conducted to evaluate the efficacy, safety, tolerability, and pharmacokinetics of masupirdine compared to placebo for the treatment of agitation in participants with dementia of the Alzheimer's type.
Trial Details
NCT Number NCT05397639
Lead Sponsor Suven Life Sciences Limited
Conditions
(from sponsor)		 Agitation, Alzheimer's Type Dementia
Related terms Psychomotor Agitation
Enrollment 375 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov