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To assess the safety and efficacy of an investigational drug, pimavanserin, in treating Parkinson disease (PD) psychosis, researchers conducted a phase III, double-blind, manufacturer-funded study. Pimavanserin is a novel selective serotonin 5-HT2A inverse agonist. The researchers randomized 199 patients to placebo or pimavanserin (40 mg daily) for 6 weeks. There was a built in 2-week nonpharmacologic lead-in phase that was designed to combat a potential placebo response. The primary outcome was the Parkinson's disease adapted scale for assessment of positive symptoms (SAPS-PD).
The analysis included 95 pimavanserin recipients and 90 placebo recipients. The pimavanserin group had a 5.79-point improvement in the SAPS-PD versus only a 2.73-poi…