TEMPO Press Release

TEMPO Press Release

Contact:
Leslie Briner
University of Rochester
585-275-1068
leslie.briner@ctcc.rochester.edu

Clinical Study Shows New Drug Helps People Affected with Parkinson's Disease

ROCHESTER, NY (December 18, 2002) - The Parkinson Study Group (PSG) reports the results of a major multi-center clinical trial of rasagiline in Parkinson's disease (PD) in the December 2002 issue of the Archives of Neurology. Two dosages of rasagiline demonstrated similar improvement in disease signs, symptoms, and quality of life compared with placebo for patients with early Parkinson's disease.

Rasagiline, a selective, irreversible, second-generation MAO-B inhibitor was tested in this trial as a single treatment for Parkinson's disease. Research physicians at 32 sites of the Parkinson Study Group (PSG) in the United States and Canada evaluated 404 patients with early Parkinson's disease in a 26-week study. Unaware of treatment assignments, study participants completed evaluations of their symptoms and quality of life, and investigators assessed the severity of their Parkinson's disease. Both active dosages -1 mg per day and 2 mg per day --- were superior compared with placebo and both doses demonstrated a profile of adverse effects similar to placebo.

The primary outcome of the study was the average change from baseline in the Total Unified Parkinson's Disease Rating Scale (UPDRS) score. The UPDRS scale is a standardized measure of patients' abilities to perform basic motor skills, as well as the effect of the disease on activities of daily living and mental abilities. As the disease progresses, patients' UPDRS scores increase.

Both active treatment groups showed a benefit when compared to placebo (P<0.001) by reducing the deterioration in the total UPDRS score by an average of 4 points. Patients who experienced less than three units deterioration in the Total UPDRS score were pre-defined as "responders". Fewer than half (49%) of placebo-treated patients were "responders" while two-thirds of rasagiline-treated patients were responders (P<0.004). Both doses of rasagiline showed benefits on a Quality of Life scale, compared with placebo.

Ira Shoulson, MD, principal investigator of the study says, "The Parkinson Study Group is working diligently to develop effective and safe treatments for Parkinson's disease. A study like this with positive results is very encouraging for us to work harder, knowing that we are closer to making a difference."

The PSG, with sponsorship from Teva Neuroscience, is also conducting studies to evaluate the effects of rasagiline in patients with more advanced PD. The PSG (www.Parkinson-Study-Group.org) is a non-profit, cooperative group of Parkinson's disease experts from medical centers in the United States and Canada who are dedicated to improving treatment for persons affected by Parkinson's disease.

PSG OVERVIEW | PARKINSON'S DISEASE OVERVIEW | WHAT IS A CLINICAL TRIAL

CLINICAL TRIALS IN PROGRESS

COMPLETED CLINICAL TRIALS | PSG / MDS SYMPOSIA | PUBLICATIONS / ABSTRACTS

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TEMPO Press Release
Contact: Leslie Briner University of Rochester 585-275-1068 leslie.briner@ctcc.rochester.edu Clinical Study Shows New Drug Helps People Affected with Parkinson's Disease ROCHESTER, NY (December 18, 2002) - The Parkinson Study Group (PSG) reports the results of a major multi-center clinical trial of rasagiline in Parkinson's disease (PD) in the December 2002 issue of the Archives of Neurology. Two dosages of rasagiline demonstrated similar improvement in disease signs, symptoms, and quality of life compared with placebo for patients with early Parkinson's disease. Rasagiline, a selective, irreversible, second-generation MAO-B inhibitor was tested in this trial as a single treatment for Parkinson's disease. Research physicians at 32 sites of the Parkinson Study Group (PSG) in the United States and Canada evaluated 404 patients with early Parkinson's disease in a 26-week study. Unaware of treatment assignments, study participants completed evaluations of their symptoms and quality of life, and investigators assessed the severity of their Parkinson's disease. Both active dosages -1 mg per day and 2 mg per day --- were superior compared with placebo and both doses demonstrated a profile of adverse effects similar to placebo. The primary outcome of the study was the average change from baseline in the Total Unified Parkinson's Disease Rating Scale (UPDRS) score. The UPDRS scale is a standardized measure of patients' abilities to perform basic motor skills, as well as the effect of the disease on activities of daily living and mental abilities. As the disease progresses, patients' UPDRS scores increase. Both active treatment groups showed a benefit when compared to placebo (P<0.001) by reducing the deterioration in the total UPDRS score by an average of 4 points. Patients who experienced less than three units deterioration in the Total UPDRS score were pre-defined as "responders". Fewer than half (49%) of placebo-treated patients were "responders" while two-thirds of rasagiline-treated patients were responders (P<0.004). Both doses of rasagiline showed benefits on a Quality of Life scale, compared with placebo. Ira Shoulson, MD, principal investigator of the study says, "The Parkinson Study Group is working diligently to develop effective and safe treatments for Parkinson's disease. A study like this with positive results is very encouraging for us to work harder, knowing that we are closer to making a difference." The PSG, with sponsorship from Teva Neuroscience, is also conducting studies to evaluate the effects of rasagiline in patients with more advanced PD. The PSG (www.Parkinson-Study-Group.org) is a non-profit, cooperative group of Parkinson's disease experts from medical centers in the United States and Canada who are dedicated to improving treatment for persons affected by Parkinson's disease.


PSG OVERVIEW \| PARKINSON'S DISEASE OVERVIEW \| WHAT IS A CLINICAL TRIAL CLINICAL TRIALS IN PROGRESS COMPLETED CLINICAL TRIALS \| PSG / MDS SYMPOSIA \| PUBLICATIONS / ABSTRACTS CONTRIBUTIONS \| OTHER USEFUL LINKS