A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease Psychosis

Acadia Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease Psychosis

Treatments: Drug: Pimavanserin tartrate (ACP-103)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00550238

ACP-103-015

Details and patient eligibility

About

To assess the long-term safety and tolerability of ACP-103 in subjects with Parkinson's disease psychosis.

Full description

This study did not have a fixed duration, and the duration of individual subject participation was determined based on investigator assessment of subject tolerability and continued benefit until such time as either the drug was commercially available in the US, or an alternate treatment extension was available in non-US regions. For this reason, no subjects, therefore, were considered to have "completed" the study.

Enrollment: 459 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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459 participants in 1 patient group

Pimavanserin tartrate (ACP-103)

Experimental group

Description:

Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects

Treatment:

Drug: Pimavanserin tartrate (ACP-103)