Status:
WITHDRAWN
A Study to Evaluate Iloperidone for the Treatment of Parkinson's Disease Psychosis
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Parkinson Disease Psychosis
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief 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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05344365
Start Date
June 1 2022
End Date
November 1 2023
Last Update
March 21 2024
Active Locations (1)
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1
Vanda Investigational Site
St. Petersburg, Florida, United States, 33713