Assessment of fampridine-PR in NMO
Research type
Research Study
Full title
A pilot study to assess efficacy of prolonged-Release oral fampridine on ambulation and visual function in Neuromyelitis Optica
IRAS ID
109687
Contact name
Martin Wilson
Contact email
Sponsor organisation
Walton Centre NHS Foundation Trust
Eudract number
2013-000529-30
Research summary
Does fampridine 10mg prolonged-release tablets improve walking speed or visual acuity in patients with neuromyelitis optica?
Background- Neuromyelitis Optica (NMO) is an inflammatory demyelinating condition of the central nervous system. Relapses typically affect the optic nerves (uni/bilateral optic neuritis) and the spinal cord (myelitis). Disability often accrues during relapses and can occur early in the disease course. There are many similarities to multiple sclerosis (MS), however the identification of a highly specific antibody (Aquaporin-4) has led to advances in the understanding of NMO as an independent disease. Unlike MS, NMO does not usually enter a progressive phase, and levels of disability are largely due to fixed impairments from previous relapses.
Prolonged-release Fampridine 10mg tablet is a potassium channel blocker that has been investigated as a treatment for MS based on a mechanism of increased action potential conduction in demyelinated nerve fibres.
Phase-3 trials in MS showed significant improvements (43%) in walking speed and leg strength in a proportion of patients (‘responders’, approx 30% of total patients). Fampridine has recently been licensed for treatment of walking impairment due to MS.
The potential benefits of Fampridine-PR is to improve walking speed and/or visual function in a group of patients with ambulatory or vision deficits due to NMO.Study Design- A pilot study where participants will be identified through purposive sampling, identified by attending the NMO service.
Each participant will take fampridine-PR 10mg tablet twice daily for 8 weeks. The duration of study will be 12 weeks in total.Funding- Biogen Idec have agreed to both supply Fampridine-PR 10mg and fund the study
REC name
North West - Haydock Research Ethics Committee
REC reference
13/NW/0502
Date of REC Opinion
9 Aug 2013
REC opinion
Further Information Favourable Opinion