Parkinson's Disease PsychosisNCT02762591
Expanded Access of Pimavanserin for Patients With PD Psychosis
A study testing Pimavanserin tartrate in people with Parkinson's Disease Psychosis, run by ACADIA Pharmaceuticals Inc..
Trial summary
The purpose of this program is to provide patients with PDP access to pimavanserin until the product receives marketing approval from the FDA and is commercially available. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson's Disease Psychosis
- What is being tested?
- Pimavanserin tartrate
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 40 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Patient meets one of the following criteria:
- Patient has participated in a previous study of pimavanserin for Parkinson's disease psychosis (PDP)
- New ("De novo") patients
- A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
- Female patients must be of non-childbearing potential
- Psychotic symptoms must have developed after Parkinson's disease diagnosis was established
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- Patient that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post-surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial
- The patient or Legally Authorized Representative (LAR) is willing and able to provide consent
- The patient or LAR is willing and able to adequately communicate in English.
Who cannot join
- Patient has a 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
- Patient has had dementia prior to or concurrently with their diagnosis of Parkinson's disease that may be inconsistent with a Parkinson's diagnosis
- Patient has 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 program
- Patient has had a myocardial infarction in last six months
- Patient has any surgery planned during the screening, treatment, or follow-up periods
- Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).
About this study
Official title: Expanded Access Program of Pimavanserin in Patients With Parkinson's Disease Psychosis
The purpose of this program is to provide patients with PDP access to pimavanserin until the product receives marketing approval from the FDA and is commercially available.
- Conditions
- Parkinson's Disease Psychosis
- Being tested
- Pimavanserin tartrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pimavanserin tartrateDrug
Pimavanserin tartrate 40 mg, tablet, taken as two 20 mg tablets, once daily by mouth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease PsychosisStudies of the same condition, open and under way.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- ACADIA Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762591
- Sponsor's protocol ID
- ACP-103-036
- Status last verified
- Apr 2017
- First submitted
- 3 May 2016
- Last updated
- 18 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program of Pimavanserin in Patients With Parkinson's Disease Psychosis
- ClinicalTrials.gov ID
- NCT02762591
- Acronym / sponsor ID
- ACP-103-036
- Conditions
- Parkinson's Disease Psychosis
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- ACADIA Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- First posted
- 5 May 2016 (estimated)
- 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.
The purpose of this program is to provide patients with PDP access to pimavanserin until the product receives marketing approval from the FDA and is commercially available.
Study design
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient meets one of the following criteria:
- A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
- Female patients must be of non-childbearing potential
- Psychotic symptoms must have developed after Parkinson's disease diagnosis was established
- Patient that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post-surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial
Key exclusion criteria (6 listed)
- Patient has a 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
- Patient has had dementia prior to or concurrently with their diagnosis of Parkinson's disease that may be inconsistent with a Parkinson's diagnosis
- Patient has 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 program
- Patient has had a myocardial infarction in last six months
- Patient has any surgery planned during the screening, treatment, or follow-up periods
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 |
|---|---|---|
| Pimavanserin tartratePimavanserin tartrate 40 mg, tablet, taken as two 20 mg tablets, once daily by mouth | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pimavanserin tartrate in people with Parkinson's Disease Psychosis, run by ACADIA Pharmaceuticals Inc..
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 9 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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.
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 18 Apr 2017.