Status:
COMPLETED
Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and Depression
Lead Sponsor:
ACADIA Pharmaceuticals Inc.
Conditions:
Treatment of Depression in Adults With Parkinson's Disease (PD)
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the efficacy of pimavanserin for the treatment of depression in adults with Parkinson's disease.
Eligibility Criteria
Inclusion
- Can understand and provide signed informed consent, request for medical records and/or subject privacy form if applicable according to local regulations
- Has a clinical diagnosis of idiopathic Parkinson's disease with a minimum duration of 1 year, defined as the presence of at least three of the following cardinal features, in the absence of alternative explanations or atypical features:
- rest tremor
- rigidity
- bradykinesia and/or akinesia
- postural and gait abnormalities
- Meets clinical criteria for depression with Parkinson's disease as listed in the NINDS/NIMH Guidelines
- If currently taking an anti-depressant, is being treated with only one SSRI or SNRI antidepressant at a dose within the US FDA-approved dose range. Subjects who are currently taking a second antidepressant or antidepressant augmentation agent at a sub-therapeutic dose or for an inadequate duration at Screening, and can be discontinued from this agent before the Baseline visit (in the opinion of the Investigator), may be eligible for the study.
- Is on a stable dose of anti-Parkinson's medication for 1 month prior to Screening
- If the subject is female, she must be of non-childbearing potential or agree to use two methods of clinically acceptable contraception
Exclusion
- Use of an antipsychotic within 3 weeks or 5 half-lives of Baseline (whichever is longer)
- Had a myocardial infarction within the 6 months prior to Screening
- Has a known personal or family history or symptoms of long QT syndrome
- Evidence of severe or medically significant hepatic or renal impairment on laboratory tests as assessed by the Investigator or Medical Monitor
- Has a history of PD psychosis, schizophrenia, or other psychotic disorder, or bipolar I or II disorder.
- Actively suicidal at Visit 1 (Screening) or Visit 2 (Baseline)
- Is pregnant or breastfeeding
- Has previously been treated with pimavanserin or is currently taking pimavanserin
- Has a sensitivity to pimavanserin or its excipients
- Is judged by the Investigator or the Medical Monitor to be inappropriate for the study
- Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
Key Trial Info
Start Date :
March 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2019
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT03482882
Start Date
March 9 2018
End Date
July 24 2019
Last Update
August 31 2020
Active Locations (21)
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1
ATP Clinical Research, Inc.
Costa Mesa, California, United States, 92626
2
The Parkinson's and Movement Disorder Institute
Fountain Valley, California, United States, 92708
3
SC3 Research-Reseda
Pasadena, California, United States, 91105
4
The Neurology Group
Pomona, California, United States, 91767