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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, baseline, week 3, week 6, week 13, week 16
Awards & highlights

AGB101 PDP Trial Summary

This trial tests if a new drug can improve psychosis symptoms in Parkinson's patients. It involves 5 visits, physical/neurological exams, questionnaires, tests, samples, & 2 MRI exams.

Who is the study for?
This trial is for people aged 40-85 with Parkinson's Disease Psychosis, experiencing symptoms at least once a week. They must be in good health, able to consent and participate fully, have adequate education or work history, and fluent in the local language. A study partner is required to assist them. Participants cannot join if they have other neurological disorders besides Parkinson's, prior severe mental illness diagnoses unrelated to Parkinson's psychosis, significant illnesses or conditions that would interfere with the study.Check my eligibility
What is being tested?
AGB101 (a low-dose form of levetiracetam) is being tested for its effectiveness in treating psychosis related to Parkinson’s disease over approximately 20 weeks. The trial involves taking AGB101 and a placebo sequentially with a break between treatments. It includes physical exams, questionnaires, cognitive tests, blood/urine samples collection and two MRI scans.See study design
What are the potential side effects?
While specific side effects are not listed here for AGB101 (levetiracetam), common ones associated with this medication can include dizziness, fatigue, coordination difficulties and behavioral changes such as agitation or aggression.

AGB101 PDP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, baseline, week 3, week 6, week 13, week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, baseline, week 3, week 6, week 13, week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in hallucinations/delusions as assessed by the Enhanced Scale for Assessment of Positive Symptoms in Parkinson's Disease (eSAPS-PD)
Secondary outcome measures
Change in hippocampal overactivity as measured by fMRI (functional Magnetic Resonance Imaging)

Side effects data

From 2014 Phase 3 trial • 361 Patients • NCT01228747
19%
Nasopharyngitis
8%
Protein urine present
6%
Pyrexia
6%
Platelet count decreased
3%
Dizziness
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Levetiracetam

AGB101 PDP 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
2,266 Previous Clinical Trials
14,837,467 Total Patients Enrolled
AgeneBioIndustry Sponsor
2 Previous Clinical Trials
1,204 Total Patients Enrolled
Arnold Bakker, Ph.D.Study DirectorJohns Hopkins University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any adults over the age of twenty eligible to participate in this trial?

"The cut-off age for inclusion in the trial is 40 years old, and it caps out at 85."

Answered by AI

Is there any danger posed by the consumption of AGB101?

"Our team at Power has given AGB101 a safety rating of 2, as the clinical trial is currently in Phase 2 and only some data exists that supports its security. No study results have been collected to suggest efficacy yet."

Answered by AI

Does this research endeavor still require participants?

"According to the clinicaltrials.gov listing, this medical trial remains open for enrollment. It was initially posted on September 1st 2023 and has seen its last edit on September 12th of the same year."

Answered by AI

How many individuals are being recruited to this investigation?

"Indeed, clinicaltrials.gov confirms that this research project is currently seeking additional participants. The trial was initially posted on September 1st 2023 and its criteria were last modified 12 days later. A total of 30 individuals need to be enrolled from a single location."

Answered by AI

Is there an opportunity to participate in this experiment?

"Eligible participants for this investigation must be between the ages of 40 and 85, diagnosed with Parkinson's disease, have completed an eighth grade level education or can demonstrate a good work history to negate mental retardation, possess satisfactory visual and auditory acuity fit for neuropsychological testing, speak the local language fluently enough to partake in all psychological assessments associated with the study, have a contact person who has at least two hours per week interaction that could help dose medication if needed as well as assess any changes from their independent evaluation. Moreover they need to meet United Kingdom brain bank criteria for PD along with presenting symptoms such as illusions; false sense of"

Answered by AI

Who else is applying?

What site did they apply to?
Johns Hopkins
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis
2023. "Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05824728.
~20 spots leftby Sep 2026
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