Parkinson Disease PsychosisPhase 2NCT05344365
A Study to Evaluate Iloperidone for the Treatment of Parkinson's Disease Psychosis
A Phase 2 study testing Iloperidone in people with Parkinson Disease Psychosis, run by Vanda Pharmaceuticals at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Parkinson Disease Psychosis
- What is being tested?
- Iloperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2022to Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Vanda Investigational Site
St. Petersburg, Florida, 33713
About this study
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)
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).
- Conditions
- Parkinson Disease Psychosis
- Being tested
- Iloperidone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IloperidoneDrug
Also called VYV-683, FANAPT
oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Iloperidone (Cohort 1) | Experimental | Not described Receives: Drug: Iloperidone |
| Iloperidone (Cohort 2) | Experimental | Not described Receives: Drug: Iloperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 days and 5 weeks
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).
Measured: 8 days and 5 weeks
Pharmacokinetics of iloperidone and its metabolites following oral treatment with iloperidone.
As measured by plasma concentrations.
Measured: 8 days and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study startJun 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Why it stopped: Study was terminated for business reasons; not due to safety or efficacy concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease PsychosisStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344365
- Sponsor's protocol ID
- VP-VYV-683-2301
- Status last verified
- Mar 2024
- First submitted
- 18 Apr 2022
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05344365
- Acronym / sponsor ID
- VP-VYV-683-2301
- Conditions
- Parkinson Disease Psychosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was terminated for business reasons; not due to safety or efficacy concerns.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iloperidone (Cohort 1) | Experimental | Drug: Iloperidone |
| Iloperidone (Cohort 2) | Experimental | Drug: Iloperidone |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IloperidoneAlso: VYV-683, FANAPToral tablet | Drug | Iloperidone (Cohort 1), Iloperidone (Cohort 2) |
Primary outcome
Assessment of safety and tolerability of iloperidone in patients with Parkinson's disease psychosis.
Time frame: 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.
Reduction in positive symptoms of Parkinson's disease psychosis.
Time frame: 8 days and 5 weeks
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.
Time frame: 8 days and 5 weeks
As measured by plasma concentrations.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Iloperidone in people with Parkinson Disease Psychosis, run by Vanda Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of safety and tolerability of iloperidone in patients with Parkinson's disease psychosis. (time frame: 8 days and 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.