Phase 2
N=39
An Open-label Safety Study of Pimavanserin in Parkinson's Disease Patients
Parkinson's Disease Psychosis
Bottom Line
View on ClinicalTrials.gov: NCT01518309 ↗Enrolled (actual)
39
Serious AEs
46.2%
Results posted
Nov 2020
Primary outcome: Primary: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) — 17 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pimavanserin tartrate (ACP-103) (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- ACADIA Pharmaceuticals Inc.
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) |
17 | — |
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).
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.