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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01018485
Recruitment Status : Completed
First Posted : November 23, 2009
Last Update Posted : May 12, 2015
Eastern Health
Information provided by:
Melbourne Health

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.


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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Tremor Drug: Botulinum Toxin Type A Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Botulinum Toxin First Dose
Blinded and Randomized injection of 20 upper limbs with Botulinum Toxin Type A
Drug: Botulinum Toxin Type A
Intramuscular injection in affected limb up to 100 Units. Two doses (one placebo, one active) 3 months apart.
Other Name: Botox

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

Primary Outcome Measures :
  1. A decrease in tremor [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The safety profile of Botulinum Toxin in MS patients [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01018485

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Australia, Victoria
Melbourne Health
Melbourne, Victoria, Australia, 3050
Sponsors and Collaborators
Melbourne Health
Eastern Health
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Principal Investigator: Andrew Evans, MD Melbourne Health

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Responsible Party: Dr Andrew Evans, Royal Melbourne Hospital, Neurologist Identifier: NCT01018485     History of Changes
Other Study ID Numbers: HREC 2008.022
First Posted: November 23, 2009    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents