The Efficacy of Botulinum Toxin in Disabling Multiple Sclerosis (MS) Tremor
What it found
The main measure showed a statistically significant benefit.
“There was a significant improvement after botulinum toxin compared with that after placebo treatment in the Bain score for tremor severity at 6 weeks (p = 0.0005) and 12 weeks (p = 0.0001), writing at 6 weeks (p = 0.0001) and 12 weeks (p = 0.0003), and Archimedes spiral drawing at 6 weeks (p = 0.0006) and 12 weeks (p = 0.0002).”Read by software from the paper's abstract
6 and 12 weeks
p = tremor severity p = 0.0005 at 6 weeks and p = 0.0001 at 12 weeks; writing p = 0.0001 at 6 weeks and p = 0.0003 at 12 weeks; spiral drawing p = 0.0006 at 6 weeks and p = 0.0002 at 12 weeks
Read by software from the paper's abstract
This trial finished 16 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Botulinum toxin type a
Synaptosomal nerve-associated protein 25 (SNAP-25) hydrolytic enzyme
What it measured
Main measures
A decrease in tremor
6 months
Physical function
Other measures (1)
The safety profile of Botulinum Toxin in MS patients
6 months
Safety
Who could take part
Relapsing and progressive · 18 to 80
Inclusion Criteria: * Relapsing-remitting MS or secondary progressive MS according to the Mc Donald criteria * Age 18-80 years of age * Competent to understand and sign informed consent * Presence of symptomatic head and/or limb tremor Exclusion Criteria: * Treatment with botulinum toxin type A of any brand within the 4 months prior to enrollment * A known contraindication to Botox injection * Pregnancy
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The incidence of tremor in Multiple Sclerosis (MS) has been estimated to affect up to 2/3rds of patients. Over half of the tremors involve the upper limb and frequently lead to further disability. Medical treatment of MS tremor is generally unrewarding, although carbamazepine, clonazepam, glutethimide, hyoscine, isoniazid, ondansetron, primidone, and tetrahydrocannabinol have been reported to have some beneficial effect but published evidence of effectiveness is very limited. The investigators' experience to date suggests that many of the upper limb tremors may potentially be responsive to Botulinum toxin injection therapy. Aims: 1. The investigators aim to determine the efficacy of commonly used doses of BOTOX on the patients with symptomatic unilateral or bilateral arm tremor due to MS; and any side effects associated with this treatment.
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History
Started
Oct 2008
Main results due
Feb 2010
Finished
Jun 2010
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