This is a pilot study to explore the effects of pimavanserin and low-dose quetiapine in subjects with Parkinson's disease with neuropsychiatric symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
11
Pimavanserin 34 mg (provided as 2×17 mg encapsulated tablets) administered orally as a single dose once daily
Placebo (provided as 2 × placebo encapsulated tablets) administered orally as a single dose once daily
Quetiapine 25 mg (provided as 1×25 mg quetiapine encapsulated tablet and 1 × placebo encapsulated tablet), OR 50 mg (provided as 2×25 mg quetiapine encapsulated tablets), OR 100 mg (provided as 2×50 mg quetiapine encapsulated tablets) administered orally as a single dose once daily
Movement Disorders Center of Arizona
Scottsdale, Arizona, United States
Tucson Neuroscience Research
Tucson, Arizona, United States
Treatment-emergent Adverse Events (TEAEs)
Assess the safety and tolerability of pimavanserin in patients with PD in terms of treatment-emergent adverse events.
Time frame: 4-week treatment duration, plus 30 days treatment-free safety follow-up
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Sutter Institute for Medical Research
Sacramento, California, United States
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Hialeah, Florida, United States
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Lady Lake, Florida, United States
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Miami, Florida, United States
Infinity Clinical Research, LLC
Sunrise, Florida, United States
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Winter Park, Florida, United States
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Savannah, Georgia, United States
Hawaii Pacific Neuroscience, LLC.
Honolulu, Hawaii, United States
...and 6 more locations