Could a Low-Dose seizure drug quiet Parkinson's psychosis?
NCT ID NCT05824728
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This study tests whether AGB101, a low-dose seizure medication, can reduce hallucinations and delusions in people with Parkinson's disease. About 30 adults aged 40-85 will take the drug and a placebo at different times, with brain scans and questionnaires to track changes. The goal is to see if it safely eases psychotic symptoms without curing the underlying disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Subjects must meet all of the following inclusion criteria at screening: 1. Subjects between 40 and 85 years old (inclusive) in good general health: 1. Willing and able to consent and participate for the duration of the study. 2. Have eighth-grade education or good work history sufficient to exclude mental retardation. 3. Have visual and auditory acuity adequate for neuropsychological testing. 4. Have proficient fluency of the native local language to participate in all the neuropsychological test assessments. 2. Have a study partner who has sufficient contact (≥ 2 hours per week) with the subject to assist with dosing of study medication (if necessary) and provide assessments of any changes and an independent evaluation of the subject's functioning. 3. Have PDP as defined by all of the following criteria and consistent with the National Institute of Neurological Disorders and Stroke/National Institute of Mental Health (NINDS/NIMH) criteria: 1. Meets United Kingdom brain bank criteria for PD 2. Presence of at least one of the following symptoms * Illusions * False sense of presence * Hallucinations * Delusions 3. The symptoms of Criterion b occur after the onset of PD. 4. The symptoms of Criterion b are recurrent or continuous for 1 month. 5. The symptoms of Criterion b are not better accounted for by another cause of Parkinsonism such as dementia with Lewy bodies, psychiatric disorders such as schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features, or a general medical condition including delirium. 6. May have the following associated features: * With/without insight * With/without dementia * With/without treatment for PD 4. Patients must be experiencing symptom(s) of Criterion 3b at least once a week during the 4 weeks prior to the screening visit. 5. Patients being treated for symptom(s) of Criterion 3b must be off medication for at least 2 weeks prior to randomization. 6. Patients must be on a stable regimen of medication for PD for at least 4 weeks prior to randomization. 7. Permitted medications: 1. With potential pro-cognitive effects, such as cholinesterase inhibitors, memantine, estrogen replacement therapy, must be at a stable dose for 1 month prior to screening and expected to remain stable throughout the study 2. Antidepressants must be at a stable dose for 1 month prior to screening and expected to remain stable throughout the study. 3. Antipsychotics must be must be at a stable dose for 1 month prior to screening and expected to remain stable throughout the study. 8. Willing and able to undergo repeated MRI scans (3 Tesla) with no contraindications to MRI. 9. Participant and partner must both be willing to use an effective contraception for duration of the study and for 4 days after it. For women, effective contraception may be hormonal; for men, a condom. Exclusion Criteria: Subjects must not meet any of the following exclusion criteria at screening: 1. Use of anticonvulsant medications within 1 month prior to the baseline visit. 2. Participation in a therapeutic clinical study for any medical or psychiatric indications within 1 month of the screening visit, or at any time during the study. Subjects must understand that they may only enroll in this clinical study once; they may not enroll in any other clinical study while participating in the current study, and they may not participate in a clinical study of a drug, biologic, therapeutic device, or medical food, in which the last dose/administration was received within 1 month prior to screening. 3. History of hypersensitivity or lack of tolerability to AGB101 (levetiracetam). 4. Severe renal impairment (creatinine clearance of \< 30 mL/minute) or undergoing hemodialysis. 5. Delirium due to the presence of an acute metabolic encephalopathy secondary to infection or from any other cause as assessed by the investigator based on labs, history, and physical exam. 6. Neurological disorder other than Parkinson's disease, such as Alzheimer's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder (lifetime history; infant febrile seizures are not exclusionary), subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities, that in the opinion of the investigator might interfere with the conduct of the study. 7. Prior diagnosis of schizophrenia, bipolar disorder or other psychotic disorder other than PD-related psychosis. 8. Stereotactic surgery for deep brain stimulation (DBS), presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body that constitute a contraindication to having an MRI scan. 9. History of alcohol or substance abuse or dependence within the past 3 years (DSM-5 criteria). 10. Any significant systemic illness or unstable medical condition that could lead to difficulty in complying with the protocol requirements. 11. Any unstable medical condition that is likely to require new medical or surgical treatment during the course of the study and where such treatments might affect the collection of efficacy data. 12. Unable or unwilling to provide informed consent or to comply with study procedures. 13. Patient or caregiver unable to administer daily oral dosing of study drug. 14. Current suicidal ideation. 15. Female subjects must not be pregnant or lactating. 16. Any other reason, which in the opinion of the investigator would confound proper interpretation of the study.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Johns Hopkins
RECRUITINGBaltimore, Maryland, 21287, United States
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