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

Vanda Pharmaceuticals

Status and phase: Withdrawn; Phase 2

Conditions: Parkinson Disease Psychosis

Treatments: Drug: Iloperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT05344365

VP-VYV-683-2301

Details and patient eligibility

About

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).

Sex: All

Ages: 65+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Iloperidone (Cohort 1)

Experimental group

Treatment:

Drug: Iloperidone

Iloperidone (Cohort 2)

Experimental group

Treatment:

Drug: Iloperidone