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

Official Title: “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”

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.

Intervention(s) in this Clinical Trial

• Drug: Botulinum Toxin Type A
  • Intramuscular injection in affected limb up to 100 Units. Two doses (one placebo, one active) 3 months apart.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Botulinum Toxin First Dose
  • Blinded and Randomized injection of 20 upper limbs with Botulinum Toxin Type A
• Experimental: 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

Primary Measures

• A decrease in tremor
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• The safety profile of Botulinum Toxin in MS patients
  • Time Frame: 6 months
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Melbourne Health Other

Overall Clinical Trial Officials and Contacts

Andrew Evans, MD Principal Investigator Melbourne Health  

Overall Contact: Anneke van der Walt, MBChB 61404708880 anneke.vanderwalt@mh.org.au

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01018485

Study ID Number: HREC 2008.022

ClinicalTrials.gov Identifier: NCT01018485

Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration