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
Overview
- Phase
- Phase 3
- Intervention
- Botulinum Toxin Type A
- Conditions
- Multiple Sclerosis
- Sponsor
- Melbourne Health
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- A decrease in tremor
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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:
- 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Botulinum Toxin First Dose
Blinded and Randomized injection of 20 upper limbs with Botulinum Toxin Type A
Intervention: Botulinum Toxin Type A
Botulinum Toxin Second Dose
20 patients will receive Placebo as first dose and Botulinum Toxin as second dose injection 3 months after initiation of the study
Intervention: Botulinum Toxin Type A
Outcomes
Primary Outcomes
A decrease in tremor
Time Frame: 6 months
Secondary Outcomes
- The safety profile of Botulinum Toxin in MS patients(6 months)