Upper Limb Spasticity Clinical Trial
Official title:
Placebo-Controlled Trial of BOTOX® Versus Zanaflex® for the Treatment of Subjects With Post Stroke Upper Limb Spasticity
In this study, we will compare BOTOX® versus Zanaflex ® for the treatment of muscle
overactivity in the upper limb following stroke or brain traums. This is a critical step in
the development of local intramuscular treatment for patients with muscle overactivity
following an acute brain lesions, as opposed to the more classic oral treatments.
This study will be a multicenter, randomized, prospective, parallel, double blind study that
enrolls subjects at twelve sites (including Mt. Sinai) throughout the United States and
Europe. The purpose of this study is to evaluate the safety and efficacy of BOTOX® compared
to Zanaflex® in reducing upper limb muscle tone in post-stroke subjects, as well as
evaluating changes in muscle tone-related disability and drug-therapy tolerance. This will
be an 18 week study. Subjects are eligible if they have been medically stable with upper
limb spasticity 6 months after their first stroke. Subjects will be randomized to one of
three treatment groups: Treatment Group I - intramuscular BOTOX® plus oral placebo,
Treatment Group II - intramuscular placebo plus oral Zanaflex®, Treatment Group III -
intramuscular placebo plus oral placebo. The dose of BOTOX® will be at the discretion of the
investigator with a maximum of 500 U per subject. The dose of the Zanaflex® will be 4mg/day
to a maximum of 36mg/day. The study anticipates that 150 subjects will be enrolled to
provide sufficient information to answer the primary objective of safety and efficacy of the
study.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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