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news.Acadia Pharmaceuticals has started its second multi-center, double-blind, placebo-controlled Phase III trial designed to evaluate the safety and efficacy of pimavanserin as a treatment for Parkinson's disease psychosis.
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The trial is designed to evaluate the safety and efficacy of pimavanserin in approximately 240 patients with Parkinson’s disease psychosis (PDP). Patients in the trial will be randomized to three different study arms, which will include two different doses of pimavanserin and one placebo arm. Patients will receive oral doses of either pimavanserin or placebo once daily for six weeks in addition to stable doses of their existing dopamine replacement therapy.
The primary endpoint of the trial is antipsychotic efficacy as measured by the Scale for the Assessment of Positive Symptoms. Motoric tolerability will be an important secondary endpoint in the trial and will be measured using the Unified Parkinson’s Disease Rating Scale.
Uli Hacksell, CEO of Acadia, said: “We believe pimavanserin may provide a unique combination of antipsychotic efficacy, motoric tolerability and safety and, therefore, provides the potential for an important advance in therapy for patients suffering from PDP.”