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

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanda Pharmaceuticals
• Treatments: Iloperidone

Criteria

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