NCT01018485

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Melbourne Health · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis
• Tremor

Interventions

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

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-02-01
• Completion: 2010-06-01
• First posted: 2009-11-23
• Last updated: 2015-05-12

Locations

1 site across 1 country: Australia