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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 May 2015
• Main ID: NCT01018485
• Date of registration: 19/11/2009
• Prospective Registration: No
• Primary sponsor: Melbourne Health
• Public title: The Efficacy of Botulinum Toxin in Disabling Multiple Sclerosis (MS) Tremor
• Scientific 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
• Date of first enrolment: October 2008
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01018485
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Australia

Contacts

• Name: Andrew Evans, MD
• Affiliation: Melbourne Health

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Tremor

Multiple Sclerosis

Intervention(s)

Drug: Botulinum Toxin Type A

Primary Outcome(s)

A decrease in tremor [Time Frame: 6 months]

Secondary Outcome(s)

The safety profile of Botulinum Toxin in MS patients [Time Frame: 6 months]

Secondary ID(s)

HREC 2008.022

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eastern Health