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

Sponsor
Vanda Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05344365
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
17
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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)
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Iloperidone (Cohort 1)

Drug: Iloperidone
oral tablet
Other Names:
  • VYV-683
  • FANAPT

    		•
    Experimental: Iloperidone (Cohort 2)

    Drug: Iloperidone
    oral tablet
    Other Names:
  • VYV-683
  • FANAPT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of safety and tolerability of iloperidone in patients with Parkinson's disease psychosis. [8 days and 5 weeks]

      As measured by the incidence of adverse events and clinically significant changes in laboratory values, ECG parameters, and vital signs.

    2. Reduction in positive symptoms of Parkinson's disease psychosis. [8 days and 5 weeks]

      As measured by the Scale for the Assessment of Positive Symptoms for Parkinson's Disease Psychosis (SAPS-PD).

    3. Pharmacokinetics of iloperidone and its metabolites following oral treatment with iloperidone. [8 days and 5 weeks]

      As measured by plasma concentrations.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    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:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vanda Investigational Site Saint Petersburg Florida United States 33713

    Sponsors and Collaborators

    • Vanda Pharmaceuticals

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vanda Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT05344365
    Other Study ID Numbers:
    • VP-VYV-683-2301
    First Posted:
    Apr 25, 2022
    Last Update Posted:
    Jun 3, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Parkinson Disease
    Psychotic Disorders
    Mental Disorders
    Iloperidone

    Study Results

    No Results Posted as of Jun 3, 2022