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

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)

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05344365

Enrollment

Registered

2022-04-25

Start date

2022-06-30

Completion date

2023-11-30

Last updated

2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease Psychosis

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).

Interventions

DRUGIloperidone

oral tablet

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Assessment of safety and tolerability of iloperidone in patients with Parkinson's disease psychosis.	8 days and 5 weeks	As measured by the incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs.
Reduction in positive symptoms of Parkinson's disease psychosis.	8 days and 5 weeks	As measured by the Scale for the Assessment of Positive Symptoms for Parkinson's Disease Psychosis (SAPS-PD).
Pharmacokinetics of iloperidone and its metabolites following oral treatment with iloperidone.	8 days and 5 weeks	As measured by plasma concentrations.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026