A Phase 3 interventional study of Pimavanserin tartrate (ACP-103) and Pimavanserin tartrate (ACP-103) in Parkinson's Disease Psychosis, sponsored by ACADIA Pharmaceuticals Inc.. Completed at 50 sites in 9 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2017-05-19.
Sponsored by ACADIA Pharmaceuticals Inc. · Phase 3, Interventional, and Treatment
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 123 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →ACADIA Pharmaceuticals Inc. is the lead sponsor of 41 studies on the registry; 5 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.
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Exclusion Criteria:
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).
pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks
Drug: Pimavanserin tartrate (ACP-103)
Placebo tablet, once daily by mouth, 6 weeks
Drug: Pimavanserin tartrate (ACP-103)
pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
Drug: Pimavanserin tartrate (ACP-103)
10 mg, tablet, once daily by mouth, for six weeks
20 mg, tablet, once daily by mouth, for six weeks
Placebo, tablet, once daily by mouth, for six weeks
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.
Time frame: Each study visit (i.e. Days 1, 8, 15, 29 and 42)
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.
Time frame: Each study visit (i.e. Days 1, 8, 15, 29 and 42)
| Milestone | Placebo | Pimavanserin 10 mg | Pimavanserin 20 mg |
|---|---|---|---|
| Started | 40 | 42 | 41 |
| Completed | 32 | 38 | 35 |
| Not completed | 8 | 4 | 6 |
| Withdrew: Adverse event | 5 | 2 | 3 |
| Withdrew: Voluntary withdrawal of consent | 2 | 0 | 2 |
| Withdrew: Physician decision | 0 | 1 | 0 |
| Withdrew: At discretion of sponsor | 1 | 1 | 1 |
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.
| Scores on the SAPS H+D scale | Placebo | Pimavanserin 10 mg | Pimavanserin 20 mg |
|---|---|---|---|
| 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) |
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.
| Score on UPDRS-II+III scale. | Placebo | Pimavanserin 10 mg | Pimavanserin 20 mg |
|---|---|---|---|
| Change from Baseline | -1.8 (-4.6 to 1.0) | NA (NA to NA) | -3.9 (-6.6 to -1.2) |
| Difference of Least Squares Mean versus Placebo | NA (NA to NA) | NA (NA to NA) | -2.1 (-5.9 to 1.8) |
Collected over 6 weeks. Non-serious events are listed at a 5.00% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 2/39 (5.1%) | 12/39 (30.8%) |
| Pimavanserin 10 mg | — | 3/41 (7.3%) | 4/41 (9.8%) |
| Pimavanserin 20 mg | — | 1/41 (2.4%) | 8/41 (19.5%) |
| Event | Placebo | Pimavanserin 10 mg | Pimavanserin 20 mg |
|---|---|---|---|
| GastroenteritisInfections and infestations | 1/39 | 0/41 | 0/41 |
| DeliriumPsychiatric disorders | 1/39 | 0/41 | 0/41 |
| Mental status changesPsychiatric disorders | 1/39 | 0/41 | 0/41 |
| FallInjury, poisoning and procedural complications | 0/39 | 1/41 | 0/41 |
| Hip fractureInjury, poisoning and procedural complications | 0/39 | 1/41 | 0/41 |
| Parkinson's diseaseNervous system disorders | 0/39 | 0/41 | 1/41 |
| DelusionPsychiatric disorders | 0/39 | 1/41 | 0/41 |
| Delusional disorder, persecutory typePsychiatric disorders | 0/39 | 1/41 | 0/41 |
| Event | Placebo | Pimavanserin 10 mg | Pimavanserin 20 mg |
|---|---|---|---|
| Orthostatic hypotensionVascular disorders | 3/39 | 2/41 | 0/41 |
| FallInjury, poisoning and procedural complications | 3/39 | 2/41 | 3/41 |
| InsomniaPsychiatric disorders | 1/39 | 0/41 | 3/41 |
| SomnolenceNervous system disorders | 2/39 | 1/41 | 1/41 |
| DizzinessNervous system disorders | 2/39 | 0/41 | 1/41 |
| HallucinationPsychiatric disorders | 2/39 | 0/41 | 2/41 |
| Age, Categorical(Participants) | Placebo | 10 mg | 20 mg | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 7 | 7 | 21 |
| >=65 years | 32 | 34 | 34 | 100 |
| Age, Continuous(years) | Placebo | 10 mg | 20 mg | Total |
|---|---|---|---|---|
| Mean | 73.0 ± 7.91 | 71.0 ± 7.44 | 72.1 ± 8.15 | 72.0 ± 7.82 |
| Sex: Female, Male(Participants) | Placebo | 10 mg | 20 mg | Total |
|---|---|---|---|---|
| Female | 12 | 15 | 17 | 44 |
| Male | 27 | 26 | 24 | 77 |
| Region of Enrollment(participants) | Placebo | 10 mg | 20 mg | Total |
|---|---|---|---|---|
| United States | 18 | 17 | 18 | 53 |
| Europe | 21 | 24 | 23 | 68 |
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ACADIA Pharmaceuticals Inc.