Phase 2Active, not recruitingAge-related condition
Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis (AGB101 PDP)
- Sponsor
- Johns Hopkins University (Academic or other)
- Enrolment
- 30 planned
- Conditions
- Parkinson Disease Psychosis
- Interventions
- AGB101
- Ages
- adults, older adults
- Registry
- NCT05824728
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Change in hallucinations/delusions as assessed by the Enhanced Scale for Assessment of Positive Symptoms in Parkinson's Disease (eSAPS-PD)
History
Primary completion expected
Last registry update
Started
Registered