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

Phase 3

Completed

• Conditions: Tremor; Multiple Sclerosis
• Interventions: Drug: Botulinum Toxin Type A

• Registration Number: NCT01018485
• Lead Sponsor: 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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-11-19
• Study First Submitted QC: 2009-11-20
• Study First Posted: 2009-11-23
• Primary Completion: 2010-02
• Study Completion: 2010-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-08
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Botulinum Toxin First Dose	Botulinum Toxin Type A	Blinded and Randomized injection of 20 upper limbs with Botulinum Toxin Type A
Botulinum Toxin Second Dose	Botulinum Toxin Type A	20 patients will receive Placebo as first dose and Botulinum Toxin as second dose injection 3 months after initiation of the study

Primary Outcome Measures

Name	Time	Method
A decrease in tremor	6 months

Secondary Outcome Measures

Name	Time	Method
The safety profile of Botulinum Toxin in MS patients	6 months

Trial Locations

Locations (1)

Melbourne Health; 🇦🇺 Melbourne, Victoria, Australia