Acadia Pharma is expected to recruit approximately 200 patients at clinical sites located in North America.
Patients in the trial will be randomised on a one-to-one basis to two study arms and will receive oral doses of either 40mg of Pimavanserin or placebo once-daily for six weeks.
In the trial, the patients will also continue to receive stable doses of their existing dopamine replacement therapy used to manage the motoric symptoms of Parkinson’s disease.
The primary endpoint of the -020 Study is antipsychotic efficacy as measured using a group of nine items from the hallucinations and delusions domains of the Scale for the Assessment of Positive Symptoms (SAPS). However, Motoric tolerability will be a key secondary endpoint .
Uli Hacksell, CEO of Acadia Pharma, said: “This Phase III trial builds on the signals of efficacy observed in our earlier PDP studies and uses a refined study design that we expect will help mitigate the placebo response, reduce variability and enhance sensitivity in measuring the efficacy of pimavanserin in PDP patients.
“We believe Pimavanserin has an ideal profile to effectively treat PDP without impairing motor function and, therefore, provides the potential for an important advance in therapy for patients suffering from this large unmet medical need.”