New study in Canada evaluating the potential add-on effect
May 31, 2004
Source: Teva Pharmaceutical Industries Ltd.
A new study assessing the add-on effect of minocycline in relapsing-remitting multiple sclerosis (RRMS) patients with active disease who are treated with CopaxoneŽ (glatiramer acetate injection) has just been initiated at four major investigation sites in Canada: Calgary, Vancouver, Edmonton and Montreal.
"The primary efficacy objective of this study is to evaluate the add-on treatment effect of oral minocycline in subjects treated with a daily injection of glatiramer acetate as measured by various MRI parameters," said Dr. Luanne Metz, professor at the Department of Clinical Neuroscience of the University of Calgary, and principal investigator. "Other study objectives include the assessment of tolerability and safety of this combination."
Approximately 50 patients will be evaluated in the four designated study centers for a total duration of nine months. This study is a double blind, randomized study designed to compare the combination of glatiramer acetate plus oral minocycline to glatiramer acetate plus placebo.
"This particular study is exciting because it provides us with the perfect opportunity to determine if there are synergies between minocycline and glatiramer acetate that would provide even greater control in managing MS," added Dr. Metz.
Minocycline, an antibiotic, eliminates bacteria that cause pneumonia, acne, and infections of skin, genital and urinary systems, and the central nervous system.
CopaxoneŽ is indicated for the reduction of the frequency of relapses in relapsing-remitting MS. In controlled clinical trials, the most commonly observed adverse events associated with the use of CopaxoneŽ which occurred at a higher frequency than in placebo treated patients were: injection site reactions, vasodilation, chest pain, asthenia, infection, pain, nausea, arthralgia, anxiety and hypertonia.
CopaxoneŽ is now approved in 42 countries worldwide, including Canada, the U.S., Australia, Israel, and all the European countries. In Europe, CopaxoneŽ is marketed by Teva Pharmaceutical Industries Ltd., and Aventis Pharma. In North America, CopaxoneŽ is marketed by Teva Neuroscience.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 25 pharmaceutical companies in the world. The company develops, manufactures, and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients. Close to 90 percent of Teva's sales are in North America and Europe. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.
CopaxoneŽ is a registered trademark of Teva Pharmaceutical Industries Ltd.
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