Parkinson's Disease PsychosisPhase 3NCT00658567

A Study of 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 50 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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: 123 participants
Where: 50 sitesin 9 countries
Study dates: Mar 2008to Dec 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 Parkinson's disease 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

50 sites in 9 countries.

Country

City, postcode or hospital

50 sites in 9 countries

United States26 sites

Study site
Albany, New York, 12208
Study site
Boston, Massachusetts, 02215
Study site
Burlington, Vermont, 05401
Study site
Charlotte, North Carolina, 28204
Study site
Clinton, Michigan, 48035
Study site
Columbia, Missouri, 65201
Study site
Commack, New York, 11725
Study site
Deerfield Beach, Florida, 33064
Study site
Detroit, Michigan, 48201
Study site
Durham, North Carolina, 27705
Study site
East Lansing, Michigan, 48824
Study site
Englewood, Colorado, 80113
Study site
Farmington, Connecticut, 06030
Study site
Houston, Texas, 77030
Study site
La Habra, California, 90631
Study site
Laguna Hills, California, 92653
Study site
New Bern, North Carolina
Study site
Omaha, Nebraska, 68131
Study site
Panama City, Florida, 32405
Study site
Philadelphia, Pennsylvania, 19131
Study site
Philadelphia, Pennsylvania, 19141
Study site
Reseda, California
Study site
Sarasota, Florida, 34233
Study site
Toledo, Ohio, 43614
Study site
Ventura, California, 93003
Study site
Worcester, Massachusetts, 01655

Other trials in United States

Spain5 sites

Study site
Barcelona, 08003
Study site
Barcelona, 08036
Study site
Barcelona, 08195
Study site
Donostia / San Sebastian, 20009
Study site
Santiago de Compostela, 15706

Other trials in Spain

Italy4 sites

Study site
Chieti Scalo, 66013
Study site
Grossetto, 58100
Study site
Roma, 00163
Study site
Roma, 00185

Other trials in Italy

Poland4 sites

Study site
Bydgoszcz, 85-096
Study site
Katowice, 40-752
Study site
Lodz, 90-130
Study site
Lublin, 20-090

Other trials in Poland

Belgium3 sites

Study site
Brussels, 1090
Study site
Ottignies, 1340
Study site
Roeselare, 8800

Other trials in Belgium

Portugal3 sites

Study site
Coimbra, 3000-548
Study site
Lisbon, 1649-028
Study site
Porto, 4099-001

Other trials in Portugal

Sweden3 sites

Study site
Jönköping, SE-551 85
Study site
Linköping, SE-581 85
Study site
Stockholm, SE-112 45

Other trials in Sweden

Austria1 site

Study site
Innsbruck, 6020

Other trials in Austria

Serbia1 site

Study site
Belgrade, 11000

Other trials in Serbia

About this study

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)

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, for six weeks
Pimavanserin tartrate (ACP-103)Drug
20 mg, tablet, once daily by mouth, for six weeks
Pimavanserin tartrate (ACP-103)Drug
Placebo, tablet, once daily by mouth, for six weeks

Study groups in NCT00658567
Study group	Role	What they receive
2	Experimental	pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks Receives: Drug: Pimavanserin tartrate (ACP-103)
Placebo	Placebo comparator	Placebo tablet, once daily by mouth, 6 weeks Receives: Drug: Pimavanserin tartrate (ACP-103)
1	Experimental	pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks Receives: Drug: Pimavanserin tartrate (ACP-103)

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 1 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). The total possible score is 0 to 160 and a negative change in score indicates improvement.
Analysis Method: ANCOVA, and missing data was imputed using LOCF method. 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.

Mar 2008Dec 2009

First posted15 Apr 2008 (estimated)
Study startMar 2008
Primary completionDec 2009
Study completionDec 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: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00658567
Sponsor's protocol ID: ACP-103-014
Status last verified: Apr 2017
First submitted: 10 Apr 2008
Last updated: 19 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Parkinson's Disease Psychosis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
ClinicalTrials.gov ID: NCT00658567
Acronym / sponsor ID: ACP-103-014
Conditions: Parkinson's Disease Psychosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 123 participants (actual)
Lead sponsor: ACADIA Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 15 Apr 2008 (estimated)
Results: Posted 9 Sep 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) 20 mg, tablet, once daily by mouth, 6 weeks
Placebo	Placebo comparator	Drug: Pimavanserin tartrate (ACP-103)Placebo tablet, once daily by mouth, 6 weeks
1	Experimental	Drug: Pimavanserin tartrate (ACP-103)pimavanserin tartrate (ACP-103) 10 mg, 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 Parkinson's disease 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, for six weeks	Drug	1
Pimavanserin tartrate (ACP-103)20 mg, tablet, once daily by mouth, for six weeks	Drug	2
Pimavanserin tartrate (ACP-103)Placebo, tablet, once daily by mouth, for six weeks	Drug	Placebo

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 1 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

Results posted to the registry on 9 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	40	32
Pimavanserin 10 mg	42	38
Pimavanserin 20 mg	41	35

Primary outcome: Antipsychotic Efficacy

Time frame: Each study visit (i.e. Days 1, 8, 15, 29 and 42). Least squares mean (95% Confidence Interval). Unit: Scores on the SAPS H+D scale

Measure	Placebo n = 38	Pimavanserin 10 mg n = 38	Pimavanserin 20 mg n = 41
Change from Baseline	-4.4 (-6.5 to -2.3)	NA (NA to NA)	-6.5 (-8.5 to -4.5)
Difference of Least Squares Mean versus Placebo	NA (NA to NA)	NA (NA to NA)	-2.1 (-4.9 to 0.8)

Population analysed: This is the "Intent to Treat" population, defined as patients who received at least one dose of study drug and had both the baseline SAPS assessment and at least one post-baseline SAPS assessment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 39 (5.1%)	12 of 39 (30.8%)	Not reported
Pimavanserin 10 mg	3 of 41 (7.3%)	4 of 41 (9.8%)	Not reported
Pimavanserin 20 mg	1 of 41 (2.4%)	8 of 41 (19.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 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.

50 sites in 9 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 50 sites in 9 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 19 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 50 sites in United States, Spain, Italy, Poland, Belgium and 4 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 9 Sep 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?

On the ClinicalTrials.gov record for NCT00658567.

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 19 May 2017.