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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05344365
Other study ID # VP-VYV-683-2301
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


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
See also
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