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
Recruitment status was Recruiting
Sponsor:
Melbourne Health
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
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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:
Genetics Home Reference related topics:
multiple sclerosis
Drug Information available for:
OnabotulinumtoxinA
U.S. FDA Resources
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
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:
|
Botulinum Toxins, Type A Botulinum Toxins 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 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 June 17, 2013