A Study to Evaluate Iloperidone for the Treatment of Parkinson's Disease Psychosis (NCT05344365) | Clinical Trial Compass
WithdrawnPhase 2
A Study to Evaluate Iloperidone for the Treatment of Parkinson's Disease Psychosis
Stopped: Study was terminated for business reasons; not due to safety or efficacy concerns.
United States0Started 2022-06
Plain-language summary
This is an open-label, sequential cohorts, flexible dose study to evaluate the tolerability, safety and pharmacokinetics of iloperidone in elderly patients with Parkinson's disease psychosis (PDP).
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willing and able to provide consent and willing to complete all aspects of the study.
* Male or female patients greater or equal to 65 years of age.
* Clinical diagnosis of idiopathic Parkinson's disease with a minimum duration of 1 year
* Psychotic symptoms for at least one month and actively experiencing psychotic symptoms each week during the month prior to screening
Exclusion Criteria:
* History of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder
* Current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of safety and tolerability of iloperidone in patients with Parkinson's disease psychosis.
Timeframe: 8 days and 5 weeks
2
Reduction in positive symptoms of Parkinson's disease psychosis.
Timeframe: 8 days and 5 weeks
3
Pharmacokinetics of iloperidone and its metabolites following oral treatment with iloperidone.