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Teva starts trial of Agilect for Parkinson's disease
New York, Dec. 1 - Teva Pharmaceutical Industries Ltd. said it has begun a study to investigate whether Agilect/Azilect can slow the progression of Parkinson's disease.
The trial - the largest to date, according to Teva - will evaluate 1,100 recently diagnosed patients at 135 sites including 52 in the United States.
The study will compare newly diagnosed patients started immediately on Agilect (rasagiline tablets) to others whose use of Agilect is delayed by nine months.
"If Agilect can slow progression of PD [Parkinson's disease], we will expect to see the UPDRS scores of those treated early with Agilect to be better than those who were switched to Agilect after a delayed start," said Dr. Warren Olanow, professor and chairman of the department of neurology at Mount Sinai School of Medicine, in a news release.
"If Agilect can modify the course of PD, those treated early with Agilect should continue to do better than those whose study treatment began with placebo before being switched to Agilect."
The Unified Parkinson's Disease Rating Scale (UPDRS) is a commonly used research tool to measure a patient's ability to perform mental and motor tasks and activities of daily life.
Current therapies help improve Parkinson's disease symptoms, but none has been shown to slow, halt, or reverse the progression of the disease, Teva said.
Agilect is a second-generation, selective, irreversible monoamine oxidase type-B inhibitor that blocks the breakdown of dopamine, a substance in the brain needed to facilitate movement. Azilect has been approved by the EMEA for marketing in Europe since Feb. 22, 2005. A new drug application for Agilect for the treatment of Parkinson's disease was submitted to the U.S. Food and Drug Administration on Sept. 5.
Teva has received approvable letters from FDA and is continuing to work to resolve the outstanding issues.
Teva is a Jerusalem, Israel-based pharmaceutical company.
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