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

NCT ID: NCT01018485

Last Updated: 2015-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-06-30

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.

Conditions

Multiple Sclerosis; Tremor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Botulinum Toxin First Dose

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

Group Type: EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type: DRUG

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

Interventions

Botulinum Toxin Type A

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

Intervention Type: DRUG

Other Intervention Names

Botox

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastern Health

OTHER

Sponsor Role: collaborator

Melbourne Health

OTHER

Sponsor Role: lead

Responsible Party

Royal Melbourne Hospital, Neurologist

Principal Investigators

Andrew Evans, MD

Role: PRINCIPAL_INVESTIGATOR

Melbourne Health

Locations

Melbourne Health

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

HREC 2008.022

Identifier Type: -

Identifier Source: org_study_id