Back to resultsA Study to Evaluate Iloperidone for the Treatment of Parkinson's Disease Psychosis
Primary Purpose
Parkinson Disease Psychosis
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Iloperidone
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease Psychosis
Eligibility Criteria
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
Sites / Locations
- Vanda Investigational SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Iloperidone (Cohort 1)
Iloperidone (Cohort 2)
Arm Description
Outcomes
Primary Outcome Measures
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.
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).
Pharmacokinetics of iloperidone and its metabolites following oral treatment with iloperidone.
As measured by plasma concentrations.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05344365
Brief Title
A Study to Evaluate Iloperidone for the Treatment of Parkinson's Disease Psychosis
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease Psychosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Iloperidone (Cohort 1)
Arm Type
Experimental
Arm Title
Iloperidone (Cohort 2)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Iloperidone
Other Intervention Name(s)
VYV-683, FANAPT
Intervention Description
oral tablet
Primary Outcome Measure Information:
Title
Assessment of safety and tolerability of iloperidone in patients with Parkinson's disease psychosis.
Description
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
Title
Reduction in positive symptoms of Parkinson's disease psychosis.
Description
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
Title
Pharmacokinetics of iloperidone and its metabolites following oral treatment with iloperidone.
Description
As measured by plasma concentrations.
Time Frame
8 days and 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400
Email
clinicaltrials@vandapharma.com
Facility Information:
Facility Name
Vanda Investigational Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanda Pharmaceuticals Inc.
Phone
202-734-3400
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate Iloperidone for the Treatment of Parkinson's Disease Psychosis
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