Biogen Idec and Elan Corporation announced a global Phase 3b study that is being conducted to evaluate the effectiveness of Tysabri as a treatment for secondary-progressive multiple sclerosis (SPMS).
The Ascend study is part of an ongoing commitment of both Biogen Idec and Elan to find ways to improve the well-being of patients with multiple sclerosis. Ascend (A Study to Characterize the Efficacy of Natalizumab on Disability in SPMS) is a double-blind, placebo-controlled study with SPMS patients being randomized to receive either Tysabri 300 mg or placebo intravenously every four weeks for 96 weeks. A global study, Ascend is expected to enroll approximately 850 patients in 15 countries.
Study participants will be between the ages of 18 and 58, with a diagnosis of SPMS for at least two years; an Expanded Disability Status Scale (EDSS) score between 3.0 and 6.5, MS Severity Score of four or higher; documented, confirmed evidence of disease progression, independent of clinical relapses during the one-year prior to enrollment; and naïve to Tysabri treatment.
“The Ascend trial is investigating whether treatment with Tysabri may prevent worsening in walking, hand movement and daily functioning in these patients,” explains Aaron Miller, MD, member of the Ascend advisory board.
“One hypothesis behind the development of SPMS is that disease progression is a result of chronic inflammation in the brain tissue trapped behind the blood-brain-barrier. This causes destruction of the myelin sheath, which protects the coating around nerve fibers, as well as the progressive loss of nerve cells, which can lead to disability in MS patients,” says Richard Reynolds, professor of Cellular Neuroscience, Imperial College, London. “Preliminary data suggest that Tysabri may hinder this inflammation in the brain and reduce SPMS-related disease progression; therefore, further investigation of this hypothesis is warranted.”
Release Date: Jan. 26, 2012
Source: Biogen Idec
Source: Biogen Idec
via DDmag
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