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ARTICLE | Clinical News

Pimavanserin: Phase III data

December 3, 2012 8:00 AM UTC

Top-line data from the double-blind, North American Phase III ACP-103-020 trial in 199 patients with PDP showed that once-daily 40 mg oral pimavanserin met the primary endpoint of improving antipsychotic efficacy as measured by the mean reduction from baseline to day 43 in scores on the SAPS-PD 9-item scale vs. placebo (5.79 vs. 2.73 points, p=0.001). Pimavanserin also met the secondary endpoint of non-inferiority to placebo in maintaining motoric tolerability as measured by Parts II and III of the UPDRS from baseline to day 43. Acadia said the 95% CI for the treatment difference in UPDRS scores between treatment groups did not exceed the pre-specified non-inferiority margin of 5 points. Additionally, pimavanserin met the secondary endpoint of improving CGI-I scores vs. placebo (p=0.001).

Furthermore, pimavanserin met the exploratory endpoints of improving nighttime sleep (p=0.045) and daytime wakefulness (p=0.012) as measured by Scales for Outcomes in PD-Sleep (SCOPA) scores vs. placebo. Pimavanserin also significantly improved Caregiver Burden Scale scores vs. placebo (p=0.002). Pimavanserin was well tolerated with urinary tract infection and falls reported as the most common adverse events. Patients received placebo or once-daily 40 mg oral pimavanserin as an adjunct to stable doses of their existing anti-Parkinson's therapy following a 2-week screening period that included brief psycho-social therapy. Patients who completed the trial were eligible to enroll in an open-label safety extension study. ...