The Efficacy of Botulinum Toxin in Disabling Multiple Sclerosis (MS) Tremor

Study Overview
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Brief Summary
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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.

Official Title
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Double-Blind, Randomized, Controlled, Cross-over Comparison of Efficacy and Safety of Botulinum Toxin Type A in the Targeted Treatment of Disabling Tremor in Multiple Sclerosis

Conditions
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Tremor, Multiple Sclerosis

Intervention / Treatment
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* Drug: Botulinum Toxin Type A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum Toxin First Dose<br>Blinded and Randomized injection of 20 upper limbs with Botulinum Toxin Type A | Drug: Botulinum Toxin Type A<br>* Intramuscular injection in affected limb up to 100 Units. Two doses (one placebo, one active) 3 months apart.<br>* Other names: Botox;|
| Experimental: Botulinum Toxin Second Dose<br>20 patients will receive Placebo as first dose and Botulinum Toxin as second dose injection 3 months after initiation of the study | Drug: Botulinum Toxin Type A<br>* Intramuscular injection in affected limb up to 100 Units. Two doses (one placebo, one active) 3 months apart.<br>* Other names: Botox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A decrease in tremor |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety profile of Botulinum Toxin in MS patients |  | 6 months |