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

NCT00658567 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ACP-103-014
• Study Type: interventional
• Target: 123
• Locations: 8 countries
• Sites: 47

Brief Summary

This study will evaluate the safety and efficacy of two dose levels of pimavanserin (ACP-103) compared to placebo in patients with Parkinson's disease psychosis.

Conditions

Parkinson's Disease Psychosis

Outcome Measures

Primary Outcomes (1)

• Antipsychotic Efficacy

  Antipsychotic efficacy was defined as a decrease in the severity and/or frequency of hallucinations and/or delusions. This is measured as the change from baseline (Day 1) to Day 42 in the Scale for the Assessment of Positive Symptoms - Hallucinations and Delusions scales (SAPS-H+D) score for the ITT Analysis Set. The possible total score is 1 to 100 and a negative change in score indicates improvement. Analysis Method: Analysis of Covariance (ANCOVA) and missing data was imputed using Last Observation Carried Forward (LOCF) method.

  Each study visit (i.e. Days 1, 8, 15, 29 and 42)

Secondary Outcomes (1)

• Motor Symptoms Change From Baseline (Negative = Improvement)

  Each study visit (i.e. Days 1, 8, 15, 29 and 42)

Study Arms (3)

2

EXPERIMENTAL

pimavanserin tartrate (ACP-103) 20 mg, tablet, once daily by mouth, 6 weeks

Drug: Pimavanserin tartrate (ACP-103)

Placebo

PLACEBO COMPARATOR

Placebo tablet, once daily by mouth, 6 weeks

Drug: Pimavanserin tartrate (ACP-103)

1

EXPERIMENTAL

pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks

Drug: Pimavanserin tartrate (ACP-103)

Interventions

Pimavanserin tartrate (ACP-103) DRUG

10 mg, tablet, once daily by mouth, for six weeks

1

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
• Presence of visual and/or auditory hallucinations, and/or delusions, occurring during the four weeks prior to study screening
• Psychotic symptoms must have developed after Parkinson's disease diagnosis was established
• Subject must be on stable dose of anti-Parkinson's medication for 1 month prior to Study Day 1 (Baseline) and during the trial
• Subject that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial
• The subject is willing and able to provide consent
• Caregiver is willing and able to accompany the subject to all visits

You may not qualify if:

• Subject has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder
• Subject has received previous ablative stereotaxic surgery (i.e., pallidotomy and thalamotomy) to treat Parkinson's disease
• Subject has current evidence of a serious and or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder
• Subject has had a myocardial infarction in last six months
• Subject has any surgery planned during the screening, treatment or follow-up periods
• Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).

Sponsors & Collaborators

• ACADIA Pharmaceuticals Inc.: lead

Study Sites (50)

Unknown Facility

La Habra, California, 90631, United States

Location

Unknown Facility

Laguna Hills, California, 92653, United States

Location

Unknown Facility

Reseda, California, United States

Location

Unknown Facility

Ventura, California, 93003, United States

Location

Unknown Facility

Englewood, Colorado, 80113, United States

Location

Unknown Facility

Farmington, Connecticut, 06030, United States

Location

Unknown Facility

Deerfield Beach, Florida, 33064, United States

Location

Unknown Facility

Panama City, Florida, 32405, United States

Location

Unknown Facility

Sarasota, Florida, 34233, United States

Location

Unknown Facility

Boston, Massachusetts, 02215, United States

Location

Unknown Facility

Worcester, Massachusetts, 01655, United States

Location

Unknown Facility

Clinton, Michigan, 48035, United States

Location

Unknown Facility

Detroit, Michigan, 48201, United States

Location

Unknown Facility

East Lansing, Michigan, 48824, United States

Location

Unknown Facility

Columbia, Missouri, 65201, United States

Location

Unknown Facility

Omaha, Nebraska, 68131, United States

Location

Unknown Facility

Albany, New York, 12208, United States

Location

Unknown Facility

Commack, New York, 11725, United States

Location

Unknown Facility

Charlotte, North Carolina, 28204, United States

Location

Unknown Facility

Durham, North Carolina, 27705, United States

Location

Unknown Facility

New Bern, North Carolina, United States

Location

Unknown Facility

Toledo, Ohio, 43614, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19131, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19141, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Burlington, Vermont, 05401, United States

Location

Unknown Facility

Innsbruck, 6020, Austria

Location

Unknown Facility

Brussels, 1090, Belgium

Location

Unknown Facility

Ottignies, 1340, Belgium

Location

Unknown Facility

Roeselare, 8800, Belgium

Location

Unknown Facility

Chieti Scalo, 66013, Italy

Location

Unknown Facility

Grossetto, 58100, Italy

Location

Unknown Facility

Roma, 00163, Italy

Location

Unknown Facility

Roma, 00185, Italy

Location

Unknown Facility

Bydgoszcz, 85-096, Poland

Location

Unknown Facility

Katowice, 40-752, Poland

Location

Unknown Facility

Lodz, 90-130, Poland

Location

Unknown Facility

Lublin, 20-090, Poland

Location

Unknown Facility

Coimbra, 3000-548, Portugal

Location

Unknown Facility

Lisbon, 1649-028, Portugal

Location

Unknown Facility

Porto, 4099-001, Portugal

Location

Unknown Facility

Belgrade, 11000, Serbia

Location

Unknown Facility

Barcelona, 08003, Spain

Location

Unknown Facility

Barcelona, 08036, Spain

Location

Unknown Facility

Barcelona, 08195, Spain

Location

Unknown Facility

Donostia / San Sebastian, 20009, Spain

Location

Unknown Facility

Santiago de Compostela, 15706, Spain

Location

Unknown Facility

Jönköping, SE-551 85, Sweden

Location

Unknown Facility

Linköping, SE-581 85, Sweden

Location

Unknown Facility

Stockholm, SE-112 45, Sweden

Location

MeSH Terms

Interventions

pimavanserin

Results Point of Contact

• Title: Roger Mills, MD
• Organization: ACADIA Pharmaceuticals Inc.

rmills@acadia-pharm.com

858-202-7563

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2008
• First Posted: April 15, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 19, 2017
• Results First Posted: September 9, 2014

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3); PT (3); AU (1); ES (5); SE (1); IT (4); PL (4); US (26)