Trial · NCT00477672
A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
NCT00477672, Phase 3, Completed, ACADIA Pharmaceuticals Inc.; results first posted 2014-03-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis. Trials, record NCT00477672. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00477672
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
- NCT number
- NCT00477672
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 298 participants, actual
- Lead sponsor
- ACADIA Pharmaceuticals Inc.
- Conditions
- Parkinson's Disease Psychosis
- Interventions
- Pimavanserin tartrate (ACP-103), Pimavanserin tartrate (ACP-103), Placebo
- First posted
- 2007-05-24
- Last updated
- 2017-05-17
- Results first posted
- 2014-03-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Antipsychotic Efficacy | 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. |
| Secondary | Motor Symptoms Change From Baseline (Negative = Improvement) | Each study visit (i.e. Days 1, 8, 15, 29 and 42) | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Antipsychotic Efficacy | Each study visit (i.e. Days 1, 8, 15, 29 and 42) | 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. | Score on the SAPS H+D scale | LEAST_SQUARES_MEAN |
| SECONDARY | Motor Symptoms Change From Baseline (Negative = Improvement) | Each study visit (i.e. Days 1, 8, 15, 29 and 42) | This is the Per Protocol population, which includes subjects in the ITT analysis set, who were free of important protocol deviations, as defined before database lock and unblinding. Subjects were analyzed according to the treatment actually received. | Score on UPDRS-II+III | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Antipsychotic Efficacy | Placebo | Change from Baseline | -5.9 | 95% Confidence Interval 7.90 | Score on the SAPS H+D scale |
| Antipsychotic Efficacy | Pimavanserin 10 mg | Change from Baseline | -5.8 | 95% Confidence Interval 9.77 | Score on the SAPS H+D scale |
| Antipsychotic Efficacy | Pimavanserin 40 mg | Change from Baseline | -6.7 | 95% Confidence Interval 7.87 | Score on the SAPS H+D scale |
| Antipsychotic Efficacy | Placebo | Difference of Least Squares Mean versus Placebo | NA | 95% Confidence Interval NA to NA | Score on the SAPS H+D scale |
| Antipsychotic Efficacy | Pimavanserin 10 mg | Difference of Least Squares Mean versus Placebo | 0.1 | 95% Confidence Interval -1.7 to 2.0 | Score on the SAPS H+D scale |
| Antipsychotic Efficacy | Pimavanserin 40 mg | Difference of Least Squares Mean versus Placebo | -0.8 | 95% Confidence Interval -2.7 to 1.1 | Score on the SAPS H+D scale |
| Motor Symptoms Change From Baseline (Negative = Improvement) | Placebo | Change from Baseline | -2.94 | 95% Confidence Interval -5.08 to -0.80 | Score on UPDRS-II+III |
| Motor Symptoms Change From Baseline (Negative = Improvement) | Pimavanserin 10 mg | Change from Baseline | -1.41 | 95% Confidence Interval -3.58 to 0.76 | Score on UPDRS-II+III |
| Motor Symptoms Change From Baseline (Negative = Improvement) | Pimavanserin 40 mg | Change from Baseline | -3.13 | 95% Confidence Interval -5.34 to -0.91 | Score on UPDRS-II+III |
| Motor Symptoms Change From Baseline (Negative = Improvement) | Placebo | Difference of Least Square Mean versus Placebo | NA | 95% Confidence Interval NA to NA | Score on UPDRS-II+III |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 98 | |
| Overall Study | STARTED | Pimavanserin 10 mg | 101 | |
| Overall Study | STARTED | Pimavanserin 40 mg | 99 | |
| Overall Study | COMPLETED | Placebo | 91 | |
| Overall Study | COMPLETED | Pimavanserin 10 mg | 85 | |
| Overall Study | COMPLETED | Pimavanserin 40 mg | 83 | |
| Overall Study | NOT COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Pimavanserin 10 mg | 16 | |
| Overall Study | NOT COMPLETED | Pimavanserin 40 mg | 16 |
Source ClinicalTrials.gov
Adverse events72
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Placebo | 4 | 98 | 4 |
| other | Nausea | Gastrointestinal disorders | Pimavanserin 10 mg | 4 | 99 | 5 |
| other | Nausea | Gastrointestinal disorders | Pimavanserin 40 mg | 8 | 98 | 10 |
| other | Constipation | Gastrointestinal disorders | Placebo | 3 | 98 | 4 |
| other | Constipation | Gastrointestinal disorders | Pimavanserin 10 mg | 4 | 99 | 5 |
| other | Constipation | Gastrointestinal disorders | Pimavanserin 40 mg | 5 | 98 | 5 |
| other | Edema | General disorders | Placebo | 1 | 98 | 1 |
| other | Edema | General disorders | Pimavanserin 10 mg | 2 | 99 | 3 |
| other | Edema | General disorders | Pimavanserin 40 mg | 7 | 98 | 7 |
| other | Fall | Injury, poisoning and procedural complications | Placebo | 11 | 98 | 12 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Pimavanserin 10 mg | ||
| Total, all-cause mortality | Pimavanserin 40 mg | ||
| Total, other adverse events | Placebo | 34 | 98 |
| Total, other adverse events | Pimavanserin 10 mg | 29 | 99 |
| Total, other adverse events | Pimavanserin 40 mg | 27 | 98 |
| Total, serious adverse events | Placebo | 2 | 98 |
| Total, serious adverse events | Pimavanserin 10 mg | 5 | 99 |
| Total, serious adverse events | Pimavanserin 40 mg | 5 | 98 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00477672
GET https://conductscience.org/api/trials/v1/NCT00477672/events?page=2