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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05824728
Phase
PHASE2
Status
Recruiting
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Conditions

  • Parkinson Disease Psychosis

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • AGB101 — DRUG
    low-dose levetiracetam, 220 mg, extended release tablet

Study Details

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.

Key Dates

Start date
Sep 28, 2023
Status verified
Oct 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: AGB101 first, then placebo
    AGB101 (low-dose levetiracetam, 220 mg, extended release tablet) once daily for 6 weeks, washout (4 weeks), then placebo capsule once daily for 6 weeks.
  • Experimental: placebo first, then AGB101
    Placebo capsule once daily for 6 weeks, washout (4 weeks), then AGB101 (low-dose levetiracetam, 220 mg, extended release tablet) once daily for 6 weeks.

Primary Outcome Measure

Change in hallucinations/delusions as assessed by the Enhanced Scale for Assessment of Positive Symptoms in Parkinson's Disease (eSAPS-PD) [ Time Frame: Screening, Baseline, Week 3, Week 6, Week 13, Week 16 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns HopkinsBaltimoreMaryland21287
Caroline Wagandt, BA
[email protected]
410-502-4797
Christopher Morrow, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Johns Hopkins· Baltimore, MD

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