Risk of Mortality Associated With Pimavanserin Use Compared With Other Atypical Antipsychotics in Patients With Parkinson’s Disease–Related Psychosis

Study identification

• EU PAS number:
  EUPAS46331
• Study ID:
  50226
• Official title and acronym:
  Risk of Mortality Associated With Pimavanserin Use Compared With Other Atypical Antipsychotics in Patients With Parkinson’s Disease–Related Psychosis
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Pimavanserin is approved in the United States (US) for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis (PDP). ; The main objective of this study is to compare the risk of mortality among patients with PDP after initiation of pimavanserin with the risk of mortality after initiation of comparator atypical antipsychotics (i.e., clozapine, quetiapine, risperidone, olanzapine, aripiprazole, or brexpiprazole). ; The evaluation of the study’s primary objective will consist of an observational (noninterventional), population-based cohort of patients with PDP. ; This study will be conducted using information collected in US Medicare claims data.
• Study status:
  Finalised

Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Study timelines

Date when funding contract was signed

Planned:20/10/2020

Actual:20/10/2020

Study start date

Planned:30/09/2021

Actual:22/10/2021

Date of interim report, if expected

Planned:31/03/2022

Actual:24/03/2022

Date of final study report

Planned:31/03/2024

Actual:02/06/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Acadia Pharmaceuticals Inc.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable