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

Parkinson's Disease Psychosis Clinical Trial

Official title:

A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00550238
• Other study ID #: ACP-103-015
• Status: Completed
• Phase: Phase 3
• Start date: July 2007
• Est. completion date: May 30, 2018

Study information

• Verified date: May 2019
• Source: ACADIA Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 459
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Parkinson Disease
• Parkinson's Disease Psychosis
• Psychotic Disorders

Intervention

Drug:
• Pimavanserin tartrate (ACP-103)
Tablets taken once daily by mouth for as long as ACP-103 is considered to be tolerated and beneficial to subjects

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ACADIA Pharmaceuticals Inc.

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  France,  India,  Italy,  Poland,  Portugal,  Russian Federation,  Serbia,  Sweden,  Ukraine,  United Kingdom, 

References & Publications (1)

Mathis MV, Muoio BM, Andreason P, Avila AM, Farchione T, Atrakchi A, Temple RJ. The US Food and Drug Administration's Perspective on the New Antipsychotic Pimavanserin. J Clin Psychiatry. 2017 Jun;78(6):e668-e673. doi: 10.4088/JCP.16r11119. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Number (%) of Patients With Drug-related Treatment-emergent Adverse Events (AEs)	Number (%) of patients with drug-related treatment-emergent AEs (i.e. AEs reported by the Investigator as possibly, probably, or highly probably related to study drug)	From first to last study drug dose plus 30 days