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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-30

Study Completion Date

2023-11-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Parkinson Disease Psychosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iloperidone (Cohort 1)

Group Type EXPERIMENTAL

Iloperidone

Intervention Type DRUG

oral tablet

Iloperidone (Cohort 2)

Group Type EXPERIMENTAL

Iloperidone

Intervention Type DRUG

oral tablet

Interventions

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Iloperidone

oral tablet

Intervention Type DRUG

Other Intervention Names

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VYV-683 FANAPT

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No