Trial · NCT00550238
A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
NCT00550238, Phase 3, Completed, ACADIA Pharmaceuticals Inc.; results first posted 2019-06-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis. Trials, record NCT00550238. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00550238
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
- NCT number
- NCT00550238
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 459 participants, actual
- Lead sponsor
- ACADIA Pharmaceuticals Inc.
- Conditions
- Parkinson's Disease Psychosis
- Interventions
- Pimavanserin tartrate (ACP-103)
- First posted
- 2007-10-29
- Last updated
- 2019-06-24
- Results first posted
- 2019-06-24
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) | From first to last study drug dose plus 30 days | Number (%) of patients with drug-related treatment-emergent AEs (i.e. AEs reported by the Investigator as possibly, probably, or highly probably related to study drug) |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) | From first to last study drug dose plus 30 days | Enrolled patients who received at least 1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) | Pimavanserin | 180 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pimavanserin | 459 | |
| Overall Study | COMPLETED | Pimavanserin | 0 | |
| Overall Study | NOT COMPLETED | Pimavanserin | 459 |
Source ClinicalTrials.gov
Adverse events214
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 | Anaemia | Blood and lymphatic system disorders | Pimavanserin | 35 | 459 | 37 |
| other | Constipation | Gastrointestinal disorders | Pimavanserin | 46 | 459 | 54 |
| other | Dysphagia | Gastrointestinal disorders | Pimavanserin | 43 | 459 | 46 |
| other | Nausea | Gastrointestinal disorders | Pimavanserin | 39 | 459 | 49 |
| other | Oedema peripheral | General disorders | Pimavanserin | 43 | 459 | 52 |
| other | Urinary tract infection | Infections and infestations | Pimavanserin | 79 | 459 | 160 |
| other | Fall | Injury, poisoning and procedural complications | Pimavanserin | 145 | 459 | 326 |
| other | Contusion | Injury, poisoning and procedural complications | Pimavanserin | 37 | 459 | 55 |
| other | Laceration | Injury, poisoning and procedural complications | Pimavanserin | 36 | 459 | 51 |
| other | Excoriation | Injury, poisoning and procedural complications | Pimavanserin | 23 | 459 | 41 |
1 to 10 of 214Source ClinicalTrials.gov
See all 214 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pimavanserin | 59 | 459 |
| Total, other adverse events | Pimavanserin | 328 | 459 |
| Total, serious adverse events | Pimavanserin | 188 | 459 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00550238
GET https://conductscience.org/api/trials/v1/NCT00550238/events?page=2