The Efficacy of Botulinum Toxin in Disabling Multiple Sclerosis (MS) Tremor
Information source: Melbourne Health
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis; Tremor
Intervention: Botulinum Toxin Type A (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Melbourne Health Official(s) and/or principal investigator(s):
Andrew Evans, MD, Principal Investigator, Affiliation: Melbourne Health
Overall contact:
Anneke van der Walt, MBChB, Phone: 61404708880, Email: anneke.vanderwalt@mh.org.au
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: A decrease in tremor
Secondary outcome: The safety profile of Botulinum Toxin in MS patients
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Anneke van der Walt, MBChB, Phone: 61404708880, Email: anneke.vanderwalt@mh.org.au
Melbourne Health, Melbourne, Victoria 3050, Australia; Recruiting
Anneke van der Walt, MBChB, Phone: 0404708880, Email: anneke.vanderwalt@mh.org.au
Anneke
Andrew H Evans, MD, Principal Investigator
Helmut Butzkueven, PhD, Principal Investigator
Anneke van der Walt, MBChB, Sub-Investigator
Additional Information
Starting date: October 2008
Last updated: November 20, 2009
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