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

Melbourne Health

Status and phase: Completed; Phase 3

Conditions: Tremor; Multiple Sclerosis

Treatments: Drug: Botulinum Toxin Type A

Study type: Interventional

Funder types: Other

Identifiers

NCT01018485

HREC 2008.022

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Botulinum Toxin First Dose

Experimental group

Description:

Blinded and Randomized injection of 20 upper limbs with Botulinum Toxin Type A

Treatment:

Drug: Botulinum Toxin Type A

Botulinum Toxin Second Dose

Experimental group

Description:

20 patients will receive Placebo as first dose and Botulinum Toxin as second dose injection 3 months after initiation of the study

Treatment:

Drug: Botulinum Toxin Type A