A Study to Evaluate Iloperidone for the Treatment of Parkinson's Disease Psychosis

Vanda Pharmaceuticals

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Parkinson Disease Psychosis

Interventions

IloperidoneDRUG

oral tablet

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Vanda Investigational Site

St. Petersburg, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 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).

Time frame: 8 days and 5 weeks

Pharmacokinetics of iloperidone and its metabolites following oral treatment with iloperidone.

As measured by plasma concentrations.

Time frame: 8 days and 5 weeks

Data from ClinicalTrials.gov

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