A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease Psychosis
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ClinicalTrials.gov Identifier: NCT01174004 |
Recruitment Status :
Completed
First Posted : August 3, 2010
Results First Posted : March 26, 2014
Last Update Posted : March 26, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson's Disease Psychosis | Drug: pimavanserin tartrate Drug: placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 199 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of Pimavanserin in the Treatment of Psychosis in Parkinson's Disease |
Study Start Date : | July 2010 |
Actual Primary Completion Date : | November 2012 |
Actual Study Completion Date : | November 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks
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Drug: pimavanserin tartrate
pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks
Other Name: ACP-103 |
Placebo Comparator: 2
placebo, tablet, once daily by mouth for 6 weeks
|
Drug: placebo
placebo, tablet, once daily by mouth for 6 weeks |
- Antipsychotic Efficacy [ Time Frame: Each study visit (i.e. Days 1, 15, 29 and 43) ]
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 43 in the Scale for the Assessment of Positive Symptoms 9-item sum score for Parkinson's Disease (SAPS-PD). The possible total score is 0 to 45 and a negative change in score indicates improvement.
Analysis Method: Mixed Model Repeated Measures (MMRM)
- Motor Symptoms Change From Baseline (Negative = Improvement) [ Time Frame: Study Days 1 and 43 ]
Motor symptoms were measured using the change from baseline to Day 43 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 possible total score is 0 to 160 and a negative change in score indicates improvement.
Analysis Method: Analysis of Covariance (ANCOVA). The UPDRS Parts II+III score was analyzed by constructing 2-sided 95% confidence intervals (CIs) on the difference between the 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.

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- Subjects that are on anti-Parkinson's medication must be on a stable dose 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
- Subject and caregiver are willing and able to adequately communicate in English for the purposes of the primary assessment
Exclusion Criteria:
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174004

Responsible Party: | ACADIA Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT01174004 |
Other Study ID Numbers: |
ACP-103-020 |
First Posted: | August 3, 2010 Key Record Dates |
Results First Posted: | March 26, 2014 |
Last Update Posted: | March 26, 2014 |
Last Verified: | February 2014 |
Parkinson Disease Psychotic Disorders Mental Disorders Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Schizophrenia Spectrum and Other Psychotic Disorders Pimavanserin Synucleinopathies |
Antiparkinson Agents Anti-Dyskinesia Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Serotonin 5-HT2 Receptor Antagonists Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |