Study identification

PURI

https://redirect.ema.europa.eu/resource/50226

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

Ongoing
Research institution and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profitENCePP partner

Contact details

Bradley Layton

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Acadia Pharmaceuticals Inc.
Study protocol
Initial protocol

0305976 PDP ACADIA mortality protocol 13AUG2021_signed_redacted

English (1001.36 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable