A Phase 3 interventional study of Pimavanserin tartrate (ACP-103) in Parkinson's Disease Psychosis, sponsored by ACADIA Pharmaceuticals Inc.. Completed at 135 sites in 14 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2019-06-24.
Sponsored by ACADIA Pharmaceuticals Inc. · Phase 3, Interventional, and Treatment
To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.
This study did not have a fixed duration, and the duration of individual subject participation was determined based on investigator assessment of subject tolerability and continued benefit until such time as either the drug was commercially available in the US, or an alternate treatment extension was available in non-US regions. For this reason, no subjects, therefore, were considered to have "completed" the study.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 459 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects
Drug: Pimavanserin tartrate (ACP-103)
Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects
Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)
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)
Time frame: From first to last study drug dose plus 30 days
Eligible patients were adult males or females with Parkinson's Disease Psychosis who had completed a prior double blind study with pimavanserin and were determined by the treating physician (Investigator) to benefit from continued treatment. This study did not have a fixed duration. Thus, no patients were considered to have "completed" the study.
| Milestone | Pimavanserin |
|---|---|
| Started | 459 |
| Completed | 0 |
| Not completed | 459 |
| Withdrew: Adverse event | 88 |
| Withdrew: Death | 34 |
| Withdrew: Disease progression | 46 |
| Withdrew: Withdrawal by subject | 167 |
| Withdrew: Physician decision | 31 |
| Withdrew: Patient noncompliance | 25 |
| Withdrew: Lost to follow-up | 13 |
| Withdrew: Sponsor decision | 55 |
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)
| Participants | Pimavanserin |
|---|---|
| Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) | 180 |
Collected over From first to last study drug dose plus 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pimavanserin | 59/459 (12.9%) | 188/459 (41%) | 328/459 (71.5%) |
| Event | Pimavanserin |
|---|---|
| PneumoniaInfections and infestations | 21/459 |
| Urinary tract infectionInfections and infestations | 17/459 |
| Pneumonia aspirationRespiratory, thoracic and mediastinal disorders | 11/459 |
| Hip fractureInjury, poisoning and procedural complications | 10/459 |
| Parkinson's diseaseNervous system disorders | 10/459 |
| DehydrationMetabolism and nutrition disorders | 9/459 |
| SyncopeNervous system disorders | 8/459 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 8/459 |
| SepsisInfections and infestations | 7/459 |
| DementiaNervous system disorders | 7/459 |
| Event | Pimavanserin |
|---|---|
| FallInjury, poisoning and procedural complications | 145/459 |
| Urinary tract infectionInfections and infestations | 79/459 |
| HallucinationPsychiatric disorders | 62/459 |
| Weight decreasedInvestigations | 57/459 |
| Confusional statePsychiatric disorders | 50/459 |
| ConstipationGastrointestinal disorders | 46/459 |
| DysphagiaGastrointestinal disorders | 43/459 |
| Oedema peripheralGeneral disorders | 43/459 |
| DizzinessNervous system disorders | 43/459 |
| AnxietyPsychiatric disorders | 41/459 |
Enrolled patients who received at least 1 dose of study drug
| Age, Continuous(years) | Pimavanserin |
|---|---|
| Mean | 71.2 ± 8.19 |
| Sex: Female, Male(Participants) | Pimavanserin |
|---|---|
| Female | 176 |
| Male | 283 |
| Race/Ethnicity, Customized(Participants) | Pimavanserin |
|---|---|
| White | 423 |
| Black/African American | 4 |
| Asian | 19 |
| Other | 13 |
| Region of Enrollment(participants) | Pimavanserin |
|---|---|
| North America | 321 |
| Europe | 120 |
| India | 18 |
Showing the first 100 of 135 sites across 14 countries.
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Plan to share: No
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ACADIA Pharmaceuticals Inc.