Orion Pharma and Novartis intend 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 8th Congress of the European Federation of Neurological Societies meeting in Paris, is scheduled to be launched this month.
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.
Stalevo, developed by Orion Pharma and marketed by Orion Pharma and Novartis, 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. "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," said Werner Poewe, Chair of the Department of Neurology at Innsbruck University, Austria. "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.
"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.
Scientific Rationale for STRIDE-PD Study
Levodopa is the most effective and most widely used symptomatic treatment of Parkinson's disease and has remained the "gold standard" of PD care for nearly 40 years. However, after several years of treatment with levodopa, people with PD often begin to experience motor complications, which include dyskinesias and motor fluctuations associated with their medication "wearing-off".
These motor complications are due in part to the advancement of the disease with a progressive loss of dopamine neurons in specific areas of the brain, and to the way traditional levodopa is administered. Levodopa is often administered two or three times daily despite its relatively short half-life (1-2 hours), which can lead to abnormal dopaminergic stimulation of the receptors, ultimately leading to the development of motor complications such as dyskinesias and "wearing-off". Administering levodopa in a more continuous manner may help delay the onset of motor complications. Based on pre-clinical study data, this hypothesis is now sought to be confirmed in STRIDE-PD with PD patients.
Stalevo is an optimized levodopa product with a significantly longer half-life than previously available levodopa preparations. This optimized profile has already been shown to significantly enhance the ability of patients with PD to control their body movements and perform basic functions such as walking and dressing versus previously available forms of levodopa.
About Parkinson's Disease
Parkinson's disease is a chronic and progressive neurological condition that affects 6.3 million people worldwide. One out of 100 people over age 60 and one per 50 people over age 80 suffer from this disease
While its cause is unknown, PD symptoms are primarily the result of degeneration of dopaminergic cells, or neurons, in the substantia nigra, a part of the brain that controls and modulates movement.
Symptoms include limbs that tremble, slowness of movement, stiffness and rigidity of limbs and gait or balance problems. As the disease progresses, these symptoms usually increase and impact a person's ability to work and function.
About Orion Pharma
Orion Pharma, the originator of entacapone and Stalevo, is a research and development-orientated pharmaceutical division of the Orion Group (HEX:ORNAS, ORNBS), which is one of the leading companies in the healthcare sector in the Nordic area of Europe. Pharmaceutical R&D at Orion Pharma focuses on three core therapy areas: CNS therapies, cardiology and critical care, and hormonal therapies. Entacapone, a COMT enzyme inhibitor used in the treatment of Parkinson's disease, is one of Orion Pharma's patented molecule discoveries. It is available globally as Comtess and Comtan, and as one of the three active compounds in the novel levodopa treatment, Stalevo. For further information please consult http://www.orion.fi.
Myllylä V, Haapaniemi T, Hartikainen P, Nuutinen J, Rissanen A, Kuopio A-M, Jolma T, Satomaa O, Kinnunen E, Kaakkola S. First experiences of new triple combination of levodopa/carbidopa/ entacapone in the treatment of patienst with Parkinson's disease (2003) Eur J Neurol 10:suppl1 (163(P2140).
Brooks D, Agid Y, Østergaard K, Widner H and Oertel W, on behalf of the TCINIT study group. A new triple combination tablet is easy to initiate and provides improved symptom control in patients with Parkinson's disease (2003) Eur J Neurol 10:Suppl1;241(P3108).
Parkinson's Disease Fact Sheet, European Parkinson's Disease Association.