A placebo-controlled, randomized, double-blind trial of the effects of modified release 4-aminopyridine on upper limb impairment in Multiple Sclerosis
A placebo-controlled, randomized, double-blind trial of the effects of modified release 4-aminopyridine (fampridine) on upper limb impairment in Multiple Sclerosis
Austin Health
60 participants
Jul 22, 2013
Interventional
Conditions
Summary
This study involves a new drug, Fampyra (modified release 4-aminopyridine) which has recently become available for the treatment of walking disability in MS. It is not yet known whether the drug could also be helpful in treating other symptoms of MS such as upper limb dysfunction or visual problems. In addition, it is not known how Fampyra works and why it seems to work better in some people than others. This study seeks to answer some of these questions by testing the effects of the drug on upper limb impairment and using a selection of clinical and electrical tests of nerve function.
Eligibility
Inclusion Criteria1
- 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.
Exclusion Criteria1
- 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.
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Interventions
Modified release oral 4-aminopyridine (fampridine) 10mg twice daily for eight weeks. Adherence will be monitored by drug tablet return.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12613000331730