Phase 3
N=459
A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis
Parkinson's Disease Psychosis
Bottom Line
View on ClinicalTrials.gov: NCT00550238 ↗Enrolled (actual)
459
Serious AEs
41.0%
Results posted
Jun 2019
Primary outcome: Primary: Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) — 180 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pimavanserin tartrate (ACP-103) (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- ACADIA Pharmaceuticals Inc.
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs) |
180 | — |
Summary
To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.
Eligibility Criteria
Inclusion Criteria
- Subject has completed the treatment period of a previous blinded study of pimavanserin
- The subject is willing and able to provide consent
- Caregiver is willing and able to accompany the subject to all visits
Exclusion Criteria
- Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
- Subject is judged by the Investigator to be inappropriate for the study
Data sourced from ClinicalTrials.gov (NCT00550238). 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.