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| Name | Class |
|---|---|
| Eastern Health | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum Toxin First Dose | Experimental | Blinded and Randomized injection of 20 upper limbs with 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin Type A | Drug | Intramuscular injection in affected limb up to 100 Units. Two doses (one placebo, one active) 3 months apart. |
|
| Measure | Description | Time Frame |
|---|---|---|
| A decrease in tremor | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The safety profile of Botulinum Toxin in MS patients | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Evans, MD | Melbourne Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Melbourne Health | Melbourne | Victoria | 3050 | Australia |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D014202 | Tremor |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |