Phase 2
Completed N=39
An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients
Source: ClinicalTrials.gov NCT01518309 ↗Enrolled (actual)
39
Serious AEs
46.2%
Results posted
Nov 2020
Primary outcomePrimary: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) — 17 Participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) |
17 | — |
Eligibility Criteria
Inclusion Criteria-
- Patients of any age, male or female with a clinical diagnosis of idiopathic Parkinson's disease, who participated in a previous (Phase II) clinical trial that evaluated pimavanserin
- Patients who may, in the opinion of the treating physician, benefit from continued therapy with pimavanserin
- Patient is willing and able to provide consent
Exclusion Criteria-
- Female patient of childbearing potential
- Patient has a clinically significant concurrent medical illness
- Patient is judged by the treating physician to be inappropriate for the study.
Data sourced from ClinicalTrials.gov (NCT01518309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.