A Phase 2 interventional study of pimavanserin tartrate (ACP-103) in Parkinson's Disease Psychosis, sponsored by ACADIA Pharmaceuticals Inc.. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2020-11-23.
Sponsored by ACADIA Pharmaceuticals Inc. · Phase 2, Interventional, and Treatment
This is an open-label extension study to assess the long-term safety and tolerability of pimavanserin (ACP-103) in subjects with Parkinson's Disease Psychosis (PDP).
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 39 is close to 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria-
Tablets taken once daily by mouth at 20, 40, or 60 mg doses
Drug: pimavanserin tartrate (ACP-103)
Tablets taken once daily by mouth at 20, 40, or 60 mg doses
Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)
Number (%) of patients with drug-related treatment-emergent AEs
Time frame: From first to last study drug dose plus 30 days
This was an open-label extension study, including patients with idiopathic Parkinson's Disease (PD) who had completed study ACP-103-006 (PD psychosis \[PDP\]) or study ACP-103-004 (PD with dyskinesias) and would benefit from continued pimavanserin treatment, as judged by the investigator.
| Milestone | Pimavanserin |
|---|---|
| Started | 39 |
| Completed | 0 |
| Not completed | 39 |
| Withdrew: Adverse event | 6 |
| Withdrew: Death | 6 |
| Withdrew: Lack of efficacy | 7 |
| Withdrew: Withdrawal by subject | 6 |
| Withdrew: Physician decision | 3 |
| Withdrew: Sponsor decision | 2 |
| Withdrew: Not in predefined categories | 9 |
Number (%) of patients with drug-related treatment-emergent AEs
| Participants | Pimavanserin |
|---|---|
| Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) | 17 |
Collected over Study treatment (median treatment duration: 475 days). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pimavanserin | 8/39 (20.5%) | 18/39 (46.2%) | 34/39 (87.2%) |
| Event | Pimavanserin |
|---|---|
| Myocardial infarctionCardiac disorders | 3/39 |
| Hip fractureInjury, poisoning and procedural complications | 3/39 |
| Subdural haematomaInjury, poisoning and procedural complications | 2/39 |
| Parkinson's diseaseNervous system disorders | 2/39 |
| Cardiac failureCardiac disorders | 1/39 |
| DiarrhoeaGastrointestinal disorders | 1/39 |
| Inguinal herniaGastrointestinal disorders | 1/39 |
| PyrexiaGeneral disorders | 1/39 |
| BronchitisInfections and infestations | 1/39 |
| CellulitisInfections and infestations | 1/39 |
| Event | Pimavanserin |
|---|---|
| ConstipationGastrointestinal disorders | 9/39 |
| HallucinationPsychiatric disorders | 9/39 |
| AnaemiaBlood and lymphatic system disorders | 8/39 |
| Urinary tract infectionInfections and infestations | 8/39 |
| FallInjury, poisoning and procedural complications | 7/39 |
| Weight decreasedInvestigations | 7/39 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 6/39 |
| Confusional stateNervous system disorders | 6/39 |
| Oedema peripheralGeneral disorders | 5/39 |
| Prothrombin time prolongedInvestigations | 5/39 |
| Age, Continuous(years) | Pimavanserin |
|---|---|
| Mean | 71.9 ± 8.28 |
| Sex: Female, Male(Participants) | Pimavanserin |
|---|---|
| Female | 10 |
| Male | 29 |
| Race/Ethnicity, Customized(Participants) | Pimavanserin |
|---|---|
| Caucasian | 38 |
| Hispanic/Latino | 1 |
| Region of Enrollment(participants) | Pimavanserin |
|---|---|
| United States | 39 |
| Clinical Global Impression of Severity(Score on a scale) | Pimavanserin |
|---|---|
| Mean | 3.6 ± 0.22 |
| UPDRS tremor(Score on a scale) | Pimavanserin |
|---|---|
| Median | 1.0 (0 to 3) |
| UPDRS duration of dyskinesias(Score on a scale) | Pimavanserin |
|---|---|
| Median | 0.0 (0 to 3) |
| UPDRS disability of dyskinesias(Score on a scale) | Pimavanserin |
|---|---|
| Median | 0.0 (0 to 4) |
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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ACADIA Pharmaceuticals Inc.