Parkinson Disease Psychosis Clinical Trial
Official title:
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)
Verified date | March 2024 |
Source | Vanda Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 2023 |
Est. primary completion date | November 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanda Investigational Site | Saint Petersburg | Florida |
Lead Sponsor | Collaborator |
---|---|
Vanda Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of safety and tolerability of iloperidone in patients with Parkinson's disease psychosis. | As measured by the incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs. | 8 days and 5 weeks | |
Primary | Reduction in positive symptoms of Parkinson's disease psychosis. | As measured by the Scale for the Assessment of Positive Symptoms for Parkinson's Disease Psychosis (SAPS-PD). | 8 days and 5 weeks | |
Primary | Pharmacokinetics of iloperidone and its metabolites following oral treatment with iloperidone. | As measured by plasma concentrations. | 8 days and 5 weeks |
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