Merck Serono initiates Parkinson’s trial

Merck Serono and its partner Newron Pharmaceuticals have initiated their Motion study which comprises of a new Phase III clinical trial of Safinamide in Parkinson’s disease.

The study will evaluate the safety and efficacy of two doses of Safinamide (50mg and 100mg once-daily) as an add-on to a single dopamine compared with dopamine agonist monotherapy.

Merck Serono, a division of Merck KGaA, has set up the Motion study as one of the Phase III trials that will make up the wider clinical development plan for Safinamide.

Expected to take place for six months, the Motion study will involve over 650 patients with early idiopathic Parkinson’s disease which will be treated with a single dopamine agonist for at least four weeks.

Patients will either receive safinamide 50mg once-daily, safinamide 100mg once-daily or placebo tablets as adjunctive treatment to dopamine agonist therapy.

The primary endpoint for the trial is the change in motor symptoms as measured by the change in the Unified Parkinson’s Disease Rating Scale.

Following an agreement with Newron in 2006, Merck Serono has exclusive worldwide rights to develop, manufacture and commericalise safinamide in Parkinson’s, Alzheimer’s and other therapeutic applications.

Earlier this month, Merck Serono announced that its US affiliate EMD Serono has received US Food and Drug Administration approval for its easypod device.