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Trial registered on ANZCTR


Registration number
ACTRN12613000331730
Ethics application status
Not yet submitted
Date submitted
21/03/2013
Date registered
25/03/2013
Date last updated
25/03/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A placebo-controlled, randomized, double-blind trial of the effects of modified release 4-aminopyridine on upper limb impairment in Multiple Sclerosis
Scientific title
A placebo-controlled, randomized, double-blind trial of the effects of modified release 4-aminopyridine (fampridine) on upper limb impairment in Multiple Sclerosis
Secondary ID [1] 282150 0
Nil
Universal Trial Number (UTN)
U1111-1140-7612
Trial acronym
FULS (Fampridine Upper Limb Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 288652 0
Condition category
Condition code
Neurological 288994 288994 0 0
Multiple sclerosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Modified release oral 4-aminopyridine (fampridine) 10mg twice daily for eight weeks. Adherence will be monitored by drug tablet return.
Intervention code [1] 286756 0
Treatment: Drugs
Comparator / control treatment
Placebo (glucose pill), oral administration, twice daily for eight weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 289110 0
Upper limb function using time to complete 9-hole peg test
Timepoint [1] 289110 0
Baseline, 2, 4, 8 weeks and 1 month after completion of treatment
Secondary outcome [1] 301836 0
Central motor conduction time measured using transcranial magnetic motor evoked potentials
Timepoint [1] 301836 0
Baseline, 4, 8 weeks and 1 month after completion of treatment
Secondary outcome [2] 301895 0
Cortical excitability measured using transcranial magnetic stimulation
Timepoint [2] 301895 0
Baseline, 4, 8 weeks and 1 month after completion of treatment
Secondary outcome [3] 301896 0
Pattern-shift visual evoked potential latency of the p100 (measured using Synergy electromyography machine)
Timepoint [3] 301896 0
Baseline, 4, 8 weeks and 1 month after completion of treatment
Secondary outcome [4] 301930 0
Upper extremity muscle strength measured using neurological examination (MRC scale of muscle power) and grip strength measured using a hand-held dynamometer
Timepoint [4] 301930 0
Baseline, 2, 4 and 8 weeks and 1 month after completion of treatment
Secondary outcome [5] 301931 0
Sensory discrimination capacity using standard indices of texture discrimination (Fabric Matching Test), limb position sense (Wrist Position Sense Test) and tactile object recognition (functional Tactile Object Recognition Test).
Timepoint [5] 301931 0
Baseline, 2, 4 and 8 weeks and 1 month after completion of treatment

Eligibility
Key inclusion criteria
Multiple sclerosis; impaired upper limb function (NB this applies to the group of 40 patients; there will also be 20 healthy controls who are being included primarily for validation of electrophysiological measurements as there are no published normal values for these parameters.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 18 years; history of seizures or epilepsy; hypersensitivity to fampridine; moderate/severe renal impairment; pregnancy; current or recent (60 days) MS relapse; alternative likely cause for upper limb impairment (e.g. peripheral neuropathy, injury); current or recent (60 days) therapy with corticosteroids; current therapy with benzodiazepines; recent (within 60 days) addition of new therapy for multiple sclerosis including disease-modifying therapies and symptomatic therapies.

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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The electrophysiological studies and clinical assessments will be assessed using repeated measures ANOVA. Correlations between changes in electrophysiology parameters and performance on the 9-hole peg test will be examined using Pearson correlation coefficients. One-way ANOVA will be used to compare the measures at baseline between fampridine responders and non-responders. This will be repeated after medication. Post hoc analysis with pairwise paired t test and Bonferroni correction will be used to compare all significant interactions.

Regarding sample size calculation: As an index of possible effect size, Goodman et al studied the response of lower limb function measured by timed 25 foot walk in patients with MS treated with Fampridine. If we assume the same effect size, to achieve a power of 80% with a significance level (alpha) of 0.05, we calculate that 38 patients in each group (fampridine, placebo) would be needed to statistically identify differences in upper limb function between the groups. However, given that there may well be differences in response based on measures of upper limb and lower limb function, a more relevant approach might be to base the calculation on the data of Erasmus et al, who assessed performance of the 9 hole peg test in patients with MS and controls. Using their figures, in order to reliably show a 40% improvement using a power of 80% and alpha 0.5, 16 patients are sufficient in drug- and placebo-treated groups. Taking into account an assumed attrition rate of 10% of the participants through the period of the study, these two approaches to sample size calculation and the feasibility of conducting a single centre study, we believe a sample size of 20 in each group, treated and placebo will provide statistically valid findings. 20 control participants are also being recruited to make a sample size total of 60.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/07/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286916 0
Commercial sector/Industry
Name [1] 286916 0
Biogen Idec
Country [1] 286916 0
Australia
Funding source category [2] 286917 0
Government body
Name [2] 286917 0
National Health and Medical Research Council (NHMRC)
Country [2] 286917 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg
VIC 3084
Country
Australia
Secondary sponsor category [1] 285705 0
None
Name [1] 285705 0
Address [1] 285705 0
Country [1] 285705 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288974 0
Austin Health Ethics Committee
Ethics committee address [1] 288974 0
Ethics committee country [1] 288974 0
Australia
Date submitted for ethics approval [1] 288974 0
25/02/2013
Approval date [1] 288974 0
Ethics approval number [1] 288974 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38590 0
Prof Richard MacDonell
Address 38590 0
Department of Neurology
Austin Health
145 Studley Road
Heidelberg
VIC 3084
Country 38590 0
Australia
Phone 38590 0
+61 3 94965529
Fax 38590 0
Email 38590 0
richard.macdonell@austin.org.au
Contact person for public queries
Name 38591 0
Marion Simpson
Address 38591 0
Department of Neurology
Austin Health
145 Studley Road
Heidelberg
VIC 3084
Country 38591 0
Australia
Phone 38591 0
+61 3 94965529
Fax 38591 0
Email 38591 0
marion.simpson@austin.org.au
Contact person for scientific queries
Name 38592 0
Marion Simpson
Address 38592 0
Department of Neurology
Austin Health
145 Studley Road
Heidelberg
VIC 3084
Country 38592 0
Australia
Phone 38592 0
+61 3 94965529
Fax 38592 0
Email 38592 0
marion.simpson@austin.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.