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Completed

NCT Number: NCT01018485

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Dyskinesias Immune System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Tremor

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Melbourne Health

Melbourne, Victoria, 3050, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A

Drug

Intramuscular injection in affected limb up to 100 Units. Two doses (one placebo, one active) 3 months apart.

Other names: Botox

Primary outcomes

  1. A decrease in tremor

    Time frame: 6 months

Secondary outcomes

  1. The safety profile of Botulinum Toxin in MS patients

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Melbourne Health

Other

Collaborators

  • Eastern Health

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 23, 2009
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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