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Anti-epileptic drug
AGB101 for Psychosis in Parkinson's Disease (AGB101 PDP Trial)
Verified Trial
Phase 2
Recruiting
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Are you between 40 and 85 years old?
You have been diagnosed with Parkinson's Disease
Timeline
Screening 4 weeks
Treatment 20 weeks
Follow Up 0 days
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if a new drug can treat hallucinations (such as seeing things that other people don’t see) and memory changes in patients with Parkinson’s disease. It involves 5 visits with physical and neurological exams, questionnaires, tests, blood and urine samples, & 2 MRI exams.
Who is the study for?
This trial is for people with Parkinson’s disease who are between 40 and 85 years old and experiencing hallucinations (such as seeing things that other people don’t see) at least once a week. Participants cannot join if they have other neurological disorders besides Parkinson’s, or a severe mental illness unrelated to Parkinson’s disease.
What is being tested?
AGB101 (a low-dose formulation of an FDA approved anti-seizure medication called levetiracetam) is being tested for its effectiveness in treating hallucinations and memory changes in Parkinson’s disease over approximately 20 weeks. The trial involves taking AGB101 and placebo sequentially with a break between treatments. It includes physical and neurological exams, questionnaires, cognitive tests, blood and urine samples, and two MRI scans.
What are the potential side effects?
While there are no known side effects low-dose levetiracetam (AGB101), common side effects associated with higher doses of levetiracetam can include dizziness, fatigue, coordination difficulties, and behavioral changes such as agitation and aggression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 4 weeks1 visit
Treatment ~ 20 weeks4 visits
Follow Up ~ 0 days0 visits
Screening ~ 4 weeks
Treatment ~ 20 weeks
Follow Up ~0 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in hallucinations/delusions as assessed by the Enhanced Scale for Assessment of Positive Symptoms in Parkinson's Disease (eSAPS-PD)
Secondary study objectives
Change in hippocampal overactivity as measured by fMRI (functional Magnetic Resonance Imaging)
Side effects data
From 2023 Phase 4 trial • 82 Patients • NCT018010728%
Seizure
5%
Stroke
3%
Patient received extra Keppra
3%
Delirium
3%
Headache
3%
Unexplained Encephalopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Levetiracetam
No Levetiracetam
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: placebo first, then AGB101Experimental Treatment1 Intervention
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.
Group II: AGB101 first, then placeboExperimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,601 Total Patients Enrolled
AgeneBioIndustry Sponsor
2 Previous Clinical Trials
224 Total Patients Enrolled
Arnold Bakker, Ph.D.Study DirectorJohns Hopkins University
Site NameJohns Hopkins
JH IRB Protocol NumberIRB00318189
Principal InvestigatorChristopher Morrow, MD