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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000331730

Acronym

FULS (Fampridine Upper Limb Study)

Enrollment

Registered

2013-03-25

Start date

2013-07-22

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

Modified release oral 4-aminopyridine (fampridine) 10mg twice daily for eight weeks. Adherence will be monitored by drug tablet return.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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.

Outcome results