Multiple Sclerosis, Tremor
Conditions
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: 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.
Interventions
DRUGBotulinum Toxin Type A
Intramuscular injection in affected limb up to 100 Units. Two doses (one placebo, one active) 3 months apart.
Sponsors
Melbourne Health
Eastern Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A decrease in tremor | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| The safety profile of Botulinum Toxin in MS patients | 6 months |
Countries
Australia
Outcome results
None listed