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Study was terminated for business reasons; not due to safety or efficacy concerns.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iloperidone (Cohort 1) | Experimental |
| |
| Iloperidone (Cohort 2) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iloperidone | Drug | oral tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | St. Petersburg | Florida | 33713 | United States |
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| ID | Term |
|---|---|
| C081732 | iloperidone |
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