Tysabri trial to evaluate use in secondary progressive MS

[MSUK]

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.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1768

[HarryZ]

It's no secret that Biogen's Tysabri sales have dropped since the introduction of the orals and the steady increase of PML cases. So they have to find another market for this drug which has been tried on SPMS patients and found ineffective.

But we know how Biogen has the ability to manipulate data ( well known in the MS world of medicine) so don't be surprised if they somehow manage to get this drug approved for SPMS use.