ACADIA Pharmaceuticals Inc. has announced that it has initiated its second Phase III trial designed to evaluate the safety and efficacy of pimavanserin as a treatment for Parkinson’s disease psychosis (PDP).
“The start of our second Phase III pivotal trial represents another important step forward toward our goal of providing a first-in-class treatment for patients with PDP,” said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA Pharmaceuticals.
Hachsell continued, “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 this debilitating disorder.”
The Phase III trial is a multi-center, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of pimavanserin in approximately 240 patients with 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, or SAPS. Motoric tolerability will be an important secondary endpoint in the trial and will be measured using the Unified Parkinson’s Disease Rating Scale, or UPDRS.
ACADIA is also currently conducting an open-label safety extension study under which patients who have completed either of the Phase III PDP trials will have the opportunity to enroll if, in the opinion of the physician, the patient may benefit from continued treatment with pimavanserin.