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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018485
• Other study ID #: HREC 2008.022
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2009
• Last updated: May 8, 2015
• Start date: October 2008
• Est. completion date: June 2010

Study information

• Verified date: May 2015
• Source: Melbourne Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis
• Tremor

Intervention

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

Locations

Country	Name	City	State
Australia	Melbourne Health	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Melbourne Health	Eastern Health

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A decrease in tremor		6 months	No
Secondary	The safety profile of Botulinum Toxin in MS patients		6 months	Yes