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

Sponsor

Melbourne Health (Other)

Overall Status

Completed

CT.gov ID

NCT01018485

Collaborator

Eastern Health (Other)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis Tremor	Drug: Botulinum Toxin Type A	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Feb 1, 2010

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Botulinum Toxin First Dose Blinded and Randomized injection of 20 upper limbs with Botulinum Toxin Type A	Drug: Botulinum Toxin Type A Intramuscular injection in affected limb up to 100 Units. Two doses (one placebo, one active) 3 months apart. Other Names: Botox
Experimental: Botulinum Toxin Second Dose 20 patients will receive Placebo as first dose and Botulinum Toxin as second dose injection 3 months after initiation of the study	Drug: Botulinum Toxin Type A Intramuscular injection in affected limb up to 100 Units. Two doses (one placebo, one active) 3 months apart. Other Names: Botox

Arm

Intervention/Treatment

Experimental: Botulinum Toxin First Dose

Blinded and Randomized injection of 20 upper limbs with Botulinum Toxin Type A

Drug: Botulinum Toxin Type A

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

Other Names:

Botox

Experimental: Botulinum Toxin Second Dose

20 patients will receive Placebo as first dose and Botulinum Toxin as second dose injection 3 months after initiation of the study

Drug: Botulinum Toxin Type A

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

Other Names:

Botox

Outcome Measures

Primary Outcome Measures

A decrease in tremor [6 months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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