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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Melbourne Health.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Eastern Health
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT01018485
First received: November 19, 2009
Last updated: November 20, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Tremor
Drug: Botulinum Toxin Type A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • A decrease in tremor [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety profile of Botulinum Toxin in MS patients [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: October 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Botox

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018485

Contacts
Contact: Anneke van der Walt, MBChB 61404708880 anneke.vanderwalt@mh.org.au
Contact: Andrew H Evans, MD 61393427000 andrewhevans@yahoo.com

Locations
Australia, Victoria
Melbourne Health Recruiting
Melbourne, Victoria, Australia, 3050
Contact: Anneke van der Walt, MBChB    0404708880    anneke.vanderwalt@mh.org.au   
Contact: Anneke         
Principal Investigator: Andrew H Evans, MD         
Principal Investigator: Helmut Butzkueven, PhD         
Sub-Investigator: Anneke van der Walt, MBChB         
Sponsors and Collaborators
Melbourne Health
Eastern Health
Investigators
Principal Investigator: Andrew Evans, MD Melbourne Health
  More Information

No publications provided

Responsible Party: Dr Andrew Evans, Royal Melbourne Hospital, Neurologist
ClinicalTrials.gov Identifier: NCT01018485     History of Changes
Other Study ID Numbers: HREC 2008.022
Study First Received: November 19, 2009
Last Updated: November 20, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Tremor
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014