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

NCT00658567 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2017-05-19

Study results available
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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

Interventions

DRUG

Pimavanserin tartrate (ACP-103)

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

DRUG

Pimavanserin tartrate (ACP-103)

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

DRUG

Pimavanserin tartrate (ACP-103)

Placebo, tablet, once daily by mouth, for six weeks

Sponsors & Collaborators

  • ACADIA Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-12-31
Completion
2009-12-31
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Italy
  • Poland
  • Portugal
  • Serbia
  • Spain
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00658567 on ClinicalTrials.gov