Parkinson's Disease PsychosisPhase 2NCT01518309
An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients
A Phase 2 study testing pimavanserin tartrate (ACP-103) in people with Parkinson's Disease Psychosis, run by ACADIA Pharmaceuticals Inc. at 1 site in United States.
Trial summary
This is an open-label extension study to assess the long-term safety and tolerability of pimavanserin (ACP-103) in subjects with Parkinson's Disease Psychosis (PDP). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease Psychosis
- What is being tested?
- pimavanserin tartrate (ACP-103)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2004to 2 May 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients of any age, male or female with a clinical diagnosis of idiopathic Parkinson's disease, who participated in a previous (Phase II) clinical trial that evaluated pimavanserin
- Patients who may, in the opinion of the treating physician, benefit from continued therapy with pimavanserin
- Patient is willing and able to provide consent
Who cannot join
- Female patient of childbearing potential
- Patient has a clinically significant concurrent medical illness
- Patient is judged by the treating physician to be inappropriate for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Safety Study of Pimavanserin in Parkinson's Disease Patients
This is an open-label extension study to assess the long-term safety and tolerability of pimavanserin (ACP-103) in subjects with Parkinson's Disease Psychosis (PDP).
- Conditions
- Parkinson's Disease Psychosis
- Being tested
- pimavanserin tartrate (ACP-103)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pimavanserin tartrate (ACP-103)Drug
Tablets taken once daily by mouth at 20, 40, or 60 mg doses
| Study group | Role | What they receive |
|---|---|---|
| pimavanserin tartrate (ACP-103) | Experimental | Tablets taken once daily by mouth at 20, 40, or 60 mg doses Receives: Drug: pimavanserin tartrate (ACP-103) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)
Number (%) of patients with drug-related treatment-emergent AEs
Measured: From first to last study drug dose plus 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study start17 Nov 2004
- Primary completion2 May 2013
- Study completion2 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- ACADIA Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518309
- Sponsor's protocol ID
- ACP-103-010
- Status last verified
- Oct 2020
- First submitted
- 16 Dec 2008
- Last updated
- 23 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Safety Study of Pimavanserin in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT01518309
- Acronym / sponsor ID
- ACP-103-010
- Conditions
- Parkinson's Disease Psychosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- ACADIA Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Nov 2004 (actual)
- Primary completion
- 2 May 2013 (actual)
- Study completion
- 2 May 2013 (actual)
- First posted
- 26 Jan 2012 (estimated)
- Results
- Posted 23 Nov 2020
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 extension study to assess the long-term safety and tolerability of pimavanserin (ACP-103) in subjects with Parkinson's Disease Psychosis (PDP).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pimavanserin tartrate (ACP-103) | Experimental | Drug: pimavanserin tartrate (ACP-103)Tablets taken once daily by mouth at 20, 40, or 60 mg doses |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of any age, male or female with a clinical diagnosis of idiopathic Parkinson's disease, who participated in a previous (Phase II) clinical trial that evaluated pimavanserin
- Patients who may, in the opinion of the treating physician, benefit from continued therapy with pimavanserin
- Patient is willing and able to provide consent
Key exclusion criteria (3 listed)
- Female patient of childbearing potential
- Patient has a clinically significant concurrent medical illness
- Patient is judged by the treating physician to be inappropriate for 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 |
|---|---|---|
| pimavanserin tartrate (ACP-103)Tablets taken once daily by mouth at 20, 40, or 60 mg doses | Drug | pimavanserin tartrate (ACP-103) |
Primary outcome
Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)
Time frame: From first to last study drug dose plus 30 days
Number (%) of patients with drug-related treatment-emergent AEs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Parkinson's Disease Psychosis
Active, not recruitingPhase 2
Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis
Parkinson Disease Psychosis
RecruitingPhase 4
Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis
Parkinson's Disease Psychosis
Recruiting
Ultra-High Resolution PET in Aging, Neurodegeneration and Psychotic Disorders
Alzheimer Dementia (AD), ALS - Amyotrophic Lateral Sclerosis
RecruitingPhase 4
Comparing Antipsychotic Medications in LBD Over Time
Parkinson's Disease Psychosis, Dementia With Lewy Bodies
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 pimavanserin tartrate (ACP-103) in people with Parkinson's Disease Psychosis, run by ACADIA Pharmaceuticals Inc. 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 23 Nov 2020. 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?
Yes. Results are posted in the registry (first posted 23 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) (time frame: From first to last study drug dose plus 30 days). 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 23 Nov 2020.