NCT05344365

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

April 18, 2022

Last Update Submit

March 19, 2024

Conditions

Parkinson Disease Psychosis

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • Pharmacokinetics of iloperidone and its metabolites following oral treatment with iloperidone.

    As measured by plasma concentrations.

    8 days and 5 weeks

Study Arms (2)

Iloperidone (Cohort 1)

EXPERIMENTAL
Drug: Iloperidone

Iloperidone (Cohort 2)

EXPERIMENTAL
Drug: Iloperidone

Interventions

IloperidoneDRUG

oral tablet

Also known as: VYV-683, FANAPT
Iloperidone (Cohort 1)Iloperidone (Cohort 2)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanda Investigational Site

St. Petersburg, Florida, 33713, United States

Location

MeSH Terms

Interventions

iloperidone
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2022

First Posted

April 25, 2022

Study Start

June 1, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

March 21, 2024

Record last verified: 2024-03

Locations

US(1)