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Cervical Dystonia
Trial shows Myobloc clinically equivalent to Botox in cervical dystonia
July 24th, 2005
In a randomized, double-blind, head-to-head trial in 111 toxin-naive subjects with cervical dystonia (CD), Myobloc (botulinum toxin type B) Injectable Solution (known as NeuroBloc in the European Union) was found to be clinically equivalent to Botox for efficacy as measured by the validated rating instrument known as TWSTRS and for duration of response. The 56 toxin-naive subjects in the Myobloc/NeuroBloc group received 10,000 U vs. 150 U for the 55 subjects in the Botox group. A statistical analysis demonstrated a clinical noninferiority endpoint, and both groups had similar adverse events. This study is one of several Myobloc studies being reported...
Source: Medical Letter on the CDC & FDA (2005-07-24)
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