Key Secondary EndpointThe key secondary endpoint of the trial evaluated motoric tolerability and functional outcome using Parts II and III of the UPDRS. The objective of this secondary endpoint was to demonstrate that pimavanserin could achieve its antipsychotic effects without worsening motor function as compared to placebo in PDP patients. A pre-specified, non-inferiority analysis was used to compare the mean change from baseline to day 43 for pimavanserin versus placebo using a two-sided 95 percent confidence interval (CI) for the treatment difference. Motoric improvements were seen in both the pimavanserin and placebo arms and the CI associated with the treatment difference did not exceed a pre-specified margin of 5 points for clinically relevant change, confirming that pimavanserin met this key secondary endpoint and did not worsen motor function in PDP patients.
ACADIA Announces Pimavanserin Meets Primary And Key Secondary Endpoints In Pivotal Phase III Parkinson’s Disease Psychosis Trial
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