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

NCT01018485 | Completed Phase 3

• 1 other identifier: HREC 2008.022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• A decrease in tremor

  6 months

Secondary Outcomes (1)

• The safety profile of Botulinum Toxin in MS patients

  6 months

Study Arms (2)

Botulinum Toxin First Dose

EXPERIMENTAL

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

Drug: Botulinum Toxin Type A

Botulinum Toxin Second Dose

EXPERIMENTAL

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

Interventions

Botulinum Toxin Type A DRUG

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

Also known as: Botox

Botulinum Toxin First Dose; Botulinum Toxin Second Dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Treatment with botulinum toxin type A of any brand within the 4 months prior to enrollment
• A known contraindication to Botox injection
• Pregnancy

Sponsors & Collaborators

• Melbourne Health: lead
• Eastern Health: collaborator

Study Sites (1)

Melbourne Health

Melbourne, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Multiple Sclerosis; Tremor

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Andrew Evans, MD

  Melbourne Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 23, 2009
• Study Start: October 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

AU (1)