Parkinson's Disease PsychosisPhase 3NCT00477672
A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
A Phase 3 study testing Pimavanserin tartrate (ACP-103) in people with Parkinson's Disease Psychosis, run by ACADIA Pharmaceuticals Inc. at 78 sites in 7 countries.
Trial summary
This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103) compared to placebo in patients with Parkinson's disease psychosis. 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 (ACP-103)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 298 participants
- Where
- 78 sitesin 7 countries
- Study dates
- Jun 2007to Jul 2009
- Phase
- Phase 3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
- Presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening
- Psychotic symptoms must have developed after PD diagnosis was established
- Subject must be on stable dose of anti-Parkinson's medication for 1 month prior to Study Day 1 (Baseline) and during the trial
- Subject 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 subject is willing and able to provide consent
- Caregiver is willing and able to accompany the subject to all visits
Who cannot join
- Subject 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
- Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinson's disease
- Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
- Subject has had a myocardial infarction in last six months
- Subject 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 protocol-specified entry criteria).
Trial locations and contacts
78 sites in 7 countries.
78 sites in 7 countries
United States36 sites
Study site
Asheville, North Carolina, 28806
Study site
Augusta, Georgia, 30912
Study site
Berkeley, California, 94705
Study site
Boca Raton, Florida, 33486
Study site
Brentwood, Tennessee, 37027
Study site
Carson, California, 90746
Study site
Columbus, Ohio, 43210
Study site
Danbury, Connecticut, 06810
Study site
Fairfield, Connecticut, 06824
Study site
Fountain Valley, California, 92708
Study site
Gainesville, Florida, 32610
Study site
Gilbert, Arizona, 85234
Study site
Irvine, California, 92697
Study site
Jacksonville, Florida, 32209
Study site
Kingston, New York, 12401
Study site
Kirkland, Washington, 98034
Study site
Miami, Florida, 33136
Study site
Phoenix, Arizona, 85013
Study site
Pompano Beach, Florida, 33060
Study site
Port Charlotte, Florida, 33952
Study site
Richmond, Virginia, 23229
Study site
Rochester, New York, 14618
Study site
Salisbury, North Carolina, 28144
Study site
San Antonio, Texas, 78258
Study site
Sarasota, Florida, 34239
Study site
Scarborough, Maine, 04074
Study site
Southfield, Michigan, 48034
Study site
Spokane, Washington, 99204
Study site
Springfield, Illinois, 62794
Study site
St. Petersburg, Florida, 33701
Study site
Sunnyvale, California, 94805
Study site
Tampa, Florida, 33606
Study site
Toms River, New Jersey, 08755
Study site
Traverse City, Michigan, 49684
Study site
Warwick, Rhode Island, 02886
Study site
Worcester, Massachusetts, 01655
India12 sites
Study site
Bangalore, 560034
Study site
Hyderabad, 500003
Study site
Karnataka, 575001
Study site
Mangalore, 575002
Study site
Mumbai, 400016
Study site
Mumbai, 400036
Study site
New Dalhi, 110060
Study site
Pune, 411004
Study site
Pune, 411030
Study site
Tamil Nadu, 600006
Study site
Tamil Nadu, 625020
Study site
Visakhapatnam, 530001
United Kingdom8 sites
Study site
Barnsley, S75 2EP
Study site
Blackburn, BB3 2HH
Study site
Brighton, BN2 5BE
Study site
Dorset, BH23 2JX
Study site
London, NW3 2PF
Study site
Newcastle upon Tyne, NE4 6BE
Study site
North Shields, NE29 8NH
Study site
Salford, M6 8HD
France6 sites
Study site
Clermont-Ferrand, 63003
Study site
Marseille, 13385
Study site
Nantes, 44093
Study site
Pessac, 33604
Study site
Strasbourg, 67091
Study site
Toulouse, 35059
Russia6 sites
Study site
Kazan', 420061
Study site
Kirov, 610014
Study site
Moscow, 125284
Study site
Saint Petersburg, 194044
Study site
Samara, 443095
Study site
Smolensk, 214018
Ukraine6 sites
Study site
Kharkiv, 61068
Study site
Kiev, 04080
Study site
Kiev, 04114
Study site
Luhansk, 91045
Study site
Lviv, 79010
Study site
Vinnytsia, 21005
Bulgaria4 sites
Study site
Pleven, 5800
Study site
Rousse, 7003
Study site
Sofia, 1113
Study site
Varna, 9010
About this study
Official title: A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease
This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103) compared to placebo in patients with Parkinson's disease psychosis.
- Conditions
- Parkinson's Disease Psychosis
- Being tested
- Pimavanserin tartrate (ACP-103), Placebo
- Keywords
- Parkinson's disease, psychotic disorders
- Medical subject headings
- Parkinson Disease, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pimavanserin tartrate (ACP-103)Drug
10 mg, tablet, once daily by mouth, 6 weeks
Pimavanserin tartrate (ACP-103)Drug
40 mg, tablet, once daily by mouth, 6 weeks
PlaceboDrug
tablet, once daily by mouth, 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Pimavanserin tartrate (ACP-103), 10 mg, tablet, once daily by mouth, 6 weeks Receives: Drug: Pimavanserin tartrate (ACP-103) |
| 3 | Experimental | Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks Receives: Drug: Pimavanserin tartrate (ACP-103) |
| 1 | Placebo comparator | Placebo tablet, once daily by mouth, 6 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antipsychotic Efficacy
Antipsychotic Efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 42 in the Scale for the Assessment of Positive Symptoms - Hallucinations and Delusions scales (SAPS-H+D) score for the ITT Analysis Set. The possible total score is 0 to 100 and a negative change in score indicates improvement.
Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method.
Measured: Each study visit (i.e. Days 1, 8, 15, 29 and 42)
Secondary outcomes (1)
Motor Symptoms Change From Baseline (Negative = Improvement)
Motor symptoms were measured using the change from baseline (Day 1) to Day 42 in the combined score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) and Part III (Motor Examination) using the per-protocol (PP) analysis set. The possible total score is 0 to 160 and a negative change in score indicates improvement.
Analysis Method: ANCOVA, and missing data was imputed using LOCF. The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between each pimavanserin dose group and placebo mean change from baseline. Non-inferiority was concluded if the upper limit of the CI was less than or equal to 5.
Measured: Each study visit (i.e. Days 1, 8, 15, 29 and 42)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startJun 2007
- Primary completionJun 2009
- Study completionJul 2009
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 298 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
- NCT00477672
- Sponsor's protocol ID
- ACP-103-012
- Status last verified
- Apr 2017
- First submitted
- 22 May 2007
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00477672
- Acronym / sponsor ID
- ACP-103-012
- Conditions
- Parkinson's Disease Psychosis
- Keywords
- Parkinson's disease, psychotic disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- ACADIA Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 24 May 2007 (estimated)
- Results
- Posted 26 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103) compared to placebo in patients with Parkinson's disease psychosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: Pimavanserin tartrate (ACP-103)Pimavanserin tartrate (ACP-103), 10 mg, tablet, once daily by mouth, 6 weeks |
| 3 | Experimental | Drug: Pimavanserin tartrate (ACP-103)Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks |
| 1 | Placebo comparator | Drug: PlaceboPlacebo tablet, once daily by mouth, 6 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
- Presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening
- Psychotic symptoms must have developed after PD diagnosis was established
- Subject must be on stable dose of anti-Parkinson's medication for 1 month prior to Study Day 1 (Baseline) and during the trial
- Subject 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)
- Subject 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
- Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinson's disease
- Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
- Subject has had a myocardial infarction in last six months
- Subject 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 tartrate (ACP-103)10 mg, tablet, once daily by mouth, 6 weeks | Drug | 2 |
| Pimavanserin tartrate (ACP-103)40 mg, tablet, once daily by mouth, 6 weeks | Drug | 3 |
| Placebotablet, once daily by mouth, 6 weeks | Drug | 1 |
Primary outcome
Antipsychotic Efficacy
Time frame: Each study visit (i.e. Days 1, 8, 15, 29 and 42)
Antipsychotic Efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 42 in the Scale for the Assessment of Positive Symptoms - Hallucinations and Delusions scales (SAPS-H+D) score for the ITT Analysis Set. The possible total score is 0 to 100 and a negative change in score indicates improvement. Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method.
1 secondary outcome
Motor Symptoms Change From Baseline (Negative = Improvement)
Time frame: Each study visit (i.e. Days 1, 8, 15, 29 and 42)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
78 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pimavanserin tartrate (ACP-103) in people with Parkinson's Disease Psychosis, run by ACADIA Pharmaceuticals Inc. at 78 sites in 7 countries.
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 7 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: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in United States, India, United Kingdom, France, Russia and 2 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 26 Mar 2014). 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?
Antipsychotic Efficacy (time frame: Each study visit (i.e. Days 1, 8, 15, 29 and 42)). 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 17 May 2017.