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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01018485




Registration number
NCT01018485
Ethics application status
Date submitted
19/11/2009
Date registered
23/11/2009
Date last updated
12/05/2015

Titles & IDs
Public title
The Efficacy of Botulinum Toxin in Disabling Multiple Sclerosis (MS) Tremor
Scientific 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
Secondary ID [1] 0 0
HREC 2008.022
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Tremor 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Botulinum Toxin Type A

Experimental: Botulinum Toxin First Dose - Blinded and Randomized injection of 20 upper limbs with Botulinum Toxin Type A

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


Treatment: Drugs: Botulinum Toxin Type A
Intramuscular injection in affected limb up to 100 Units. Two doses (one placebo, one active) 3 months apart.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
A decrease in tremor
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
The safety profile of Botulinum Toxin in MS patients
Timepoint [1] 0 0
6 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2010
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Melbourne Health - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Eastern Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01018485
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Evans, MD
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01018485