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Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis

Study acronym: AGB101 PDP
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Sep 2026 → Dec 2026
See other at-risk trials from Johns Hopkins University

Record History

  1. Primary endpoints: details revised at 1 of 1 entry Enrollment closed, study ongoing · Eligibility criteria expanded, about 45 words · Site details revised Show 3 more changesShow less
    • Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 45 words
    • Site details revised
  2. Primary and study completion pushed from Sep 2026 to Dec 2026v7
  3. 2 versions Re-verified since Oct 10, 2024, no change to tracked fieldsv5-v6
  4. Start date changed from estimate of Nov 1, 2023 to Sep 28, 2023v4
  5. Start date: Sep 2023 to Nov 1, 2023v3
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 clinical trial will test whether AGB101 (low-dose levetiracetam, 220 mg, extended release tablet) can improve symptoms of psychosis in Parkinson's disease. Participants will be asked to complete up to 5 in-person study visits over approximately 20 weeks. Participants will receive both AGB101 and a placebo to take once a day for 6 weeks, with a 4-week washout in between. Participation will also involve physical/neurological exams, questionnaires, paper and pencil tests, providing blood and urine samples, and completing two MRI exams.
Trial Details
NCT Number NCT05824728
Lead Sponsor Johns Hopkins University
Collaborators: AgeneBio
Conditions Parkinson Disease Psychosis
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov