A Phase 3 interventional study of Botulinum Toxin Type A in Multiple Sclerosis and Tremor, sponsored by Melbourne Health. Completed at 1 site in Australia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-05-12.
Sponsored by Melbourne Health · Phase 3, Interventional, and Treatment
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:
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Melbourne Health is the lead sponsor of 59 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Blinded and Randomized injection of 20 upper limbs with Botulinum Toxin Type A
Drug: Botulinum Toxin Type A
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.
Also known as: Botox
A decrease in tremor
Time frame: 6 months
The safety profile of Botulinum Toxin in MS patients
Time frame: 6 months
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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