June 26, 2014

Study assesses safety and efficacy of BOTOX® for management of tremor

An Australian research team conducted a double-blind, randomized, cross-over study of botulinum toxin type A to evaluate its safety and efficacy in treating arm tremor in people living with MS. Findings from this study suggest that BOTOX® improved arm tremor and tremor-related disability in people with MS. [Anneke Van Der Walt, MBChB, Simon Sung, MBBS, Timothy Spelman, MBBS,Mark Marriott, PhD, Scott Kolbe, PhD,Peter Mitchell, PhD,Andrew Evans, MD* and Helmut Butzkueven, PhD*. Neurology® 2012; 79:92–99]

Researchers from Melbourne, Australia conducted a double-blind, randomized, cross-over study involving twenty-three participants with MS, contributing data from 33 upper limbs to this study. Each limb was randomized in a crossover design to receive 100 IU of BOTOX type A or normal saline placebo at baseline and the reverse treatment was given at three months. The three main outcomes included: changes in Bain tremor rating scores for tremor severity, writing a standardized sentence and drawing a spiral with the dominant hand, from baseline to six and twelve weeks after treatment with BOTOX A compared with those after treatment with placebo. Randomized video assessments were performed every six weeks over a period of six months.

A significant improvement after treatment with BOTOX was observed compared with placebo treatment in all outcome measures at six and twelve weeks. Forty-two per cent of the participants developed mild to moderate weakness after BOTOX treatment compared to six per cent of those who received placebo. Weakness resolved within two weeks of treatment.  A larger Phase III study is required to confirm the findings from this promising study.