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

Phase 2

Withdrawn

• Conditions: Parkinson Disease Psychosis
• Interventions: Drug: Iloperidone

• Registration Number: NCT05344365
• Lead Sponsor: Vanda Pharmaceuticals

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-25
• Study Start: 2022-06
• Primary Completion: 2023-11
• Study Completion: 2023-11
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Iloperidone (Cohort 1)	Iloperidone	-
Iloperidone (Cohort 2)	Iloperidone	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of iloperidone and its metabolites following oral treatment with iloperidone.	8 days and 5 weeks	As measured by plasma concentrations.
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).

Trial Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 Saint Petersburg, Florida, United States