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WithdrawnNCT05344365Updated Mar 21, 2024

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

A Phase 2 interventional study of Iloperidone in Parkinson Disease Psychosis, sponsored by Vanda Pharmaceuticals. Withdrawn at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-03-21.

Sponsored by Vanda Pharmaceuticals · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Study was terminated for business reasons; not due to safety or efficacy concerns.
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
65 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Parkinson Disease Psychosis
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

Browse Parkinson Disease studies →

Lead sponsor

Vanda Pharmaceuticals is the lead sponsor of 81 studies on the registry; 18 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 22 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Iloperidone (Cohort 1)

    Drug: Iloperidone

  • Experimental
    Iloperidone (Cohort 2)

    Drug: Iloperidone

Interventions

  • DrugIloperidone

    oral tablet

    Also known as: VYV-683, FANAPT

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 days and 5 weeks

  2. 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).

    Time frame: 8 days and 5 weeks

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

    As measured by plasma concentrations.

    Time frame: 8 days and 5 weeks

07

Study locations

1 site
  • Vanda Investigational Site
    Saint Petersburg, Florida 33713, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05344365
Lead sponsor
Vanda Pharmaceuticals
Responsible party
Sponsor
First posted
Apr 25, 2022
Start date
Jun 2022 (estimated)
Primary completion
Nov 2023 (estimated)
Completion
Nov 2023 (estimated)
Last update
Mar 21, 2024

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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