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

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05344365
• Other study ID #: VP-VYV-683-2301
• Status: Withdrawn
• Phase: Phase 2
• Start date: June 2022
• Est. completion date: November 2023

Study information

• Verified date: March 2024
• Source: Vanda Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn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

Related Conditions & MeSH terms

• Mental Disorders
• Parkinson Disease
• Parkinson Disease Psychosis
• Psychotic Disorders

Intervention

Drug:
• Iloperidone
oral tablet

Locations

Country	Name	City	State
United States	Vanda Investigational Site	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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