Multiple Sclerosis | The Efficacy of Botulinum Toxin in Disabling Multiple Sclerosis (MS) Tremor
Multiple Sclerosis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Botulinum Toxin Type AIntramuscular injection in affected limb up to 100 Units. Two doses (one placebo, one active) 3 months apart.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Botulinum Toxin First DoseBlinded and Randomized injection of 20 upper limbs with Botulinum Toxin Type A
Botulinum Toxin Second Dose20 patients will receive Placebo as first dose and Botulinum Toxin as second dose injection 3 months after initiation of the study
Start Date: October 2008
Completed Date: June 2010
Phase: Phase 3
Primary Outcome: A decrease in tremor
Secondary Outcome: The safety profile of Botulinum Toxin in MS patients
Study sponsors, principal investigator, and references
Principal Investigator: Andrew Evans, MD
Lead Sponsor: Melbourne Health
Collaborator: Eastern Health