Novartis and Orion Pharma are all set to launch a major study in Parkinson's disease seeking to demonstrate that, when used as initial therapy, the optimized levodopa medication Stalevo - containing levodopa, carbidopa and entacapone - delays the onset of motor complications, such as dyskinesias, compared to patients taking a traditional formulation of levodopa/carbidopa.

The STRIDE-PD (STalevo Reduction In Dyskinesia Evaluation) study, announced at the eighth Congress of the European Federation of Neurological Societies meeting in Paris, is scheduled to be launched this month.

Stalevo, developed by Orion Pharma and marketed by Novartis and Orion Pharma in their respective territories combines levodopa with two other ingredients - carbidopa and entacapone - that extend the benefits of levodopa to permit people with PD to have an improved ability to perform everyday tasks.

"While levodopa is the most effective and most widely used treatment for PD, its long term motor complications represent a major problem. Therefore we are looking for better strategies to prevent or delay such complications. STRIDE-PD will be the first large, multi-center study to explore the potential of delaying dyskinesias with Stalevo," said Olivier Rascol, Professor of Clinical Pharmacology at the University Hospital in Toulouse, France. He added, "The scientific rationale for the STRIDE-PD study is that Stalevo may provide at least the same symptom control as traditional levodopa/carbidopa while reducing the risk of long-term side effects such as dyskinesias and wearing off."

"The importance of the STRIDE-PD study could be major. If the study shows that Stalevo is superior to traditional levodopa/carbidopa therapy in the time to onset of dyskinesias, this could change the current treatment paradigm completely," Werner Poewe, chair of the Department of Neurology at Innsbruck University, Austria said adding, "We would then use Stalevo as the type of levodopa treatment in patients needing it from the very first day."

The STRIDE-PD study will be a long-term, double-blind, active-controlled, multi-center study that includes 70 centers in 14 countries, including the United States, Canada and countries in Europe. Approximately 740 patients diagnosed with idiopathic PD will be randomized into the study. Patient recruitment will start this month and the first study results are expected in 2007.

Characterized by abnormal and involuntary movements, dyskinesias are a major challenge for people with Parkinson's disease (PD) since they can result in fragmented or jerky motions that are different from the rhythmic tremor commonly associated with PD.

"Dyskinesias are a common phenomenon after several years of levodopa treatment. These involuntary movements eventually become a serious problem for people with PD. Delaying the onset of these motor complications would offer a real improvement in the quality of life for patients and their families," said Mary Baker, president of the European Parkinson's Disease Association.

Parkinson's disease is a chronic and progressive neurological condition that affects 6.3 million people worldwide. One percent of people over age 60 and two per cent of people over age 80 suffer from this disease.