Björn Zörner1, Linard Filli2, Katja Reuter2, Sandra Kapitza2, Lilla Lörincz2, Tabea Sutter2, David Weller2, Melinda Farkas3, Christopher S Easthope4, Adam Czaplinski5, Michael Weller2, Michael Linnebank6. 1. Department of Neurology, University Hospital Zurich, Zurich, Switzerland bjoern.zoerner@usz.ch. 2. Department of Neurology, University Hospital Zurich, Zurich, Switzerland. 3. Department of Neurology, University Hospital Zurich, Zurich, Switzerland/Europe and Canada Regional Medical, Biogen International GmbH, Zug, Switzerland. 4. Spinal Cord Injury Center, Balgrist University Hospital, Zurich, Switzerland. 5. NeuroZentrum Bellevue, Zurich, Switzerland. 6. Department of Neurology, University Hospital Zurich, Zurich, Switzerland/ Department of Neurology, HELIOS-Klinik Hagen-Ambrock, Hagen, Germany.
Abstract
BACKGROUND:Prolonged-release fampridine (PR-fampridine, 4-aminopyridine) increases walking speed in the timed 25-foot walk test (T25FW) in some patients (timed-walk responders) with multiple sclerosis (MS). OBJECTIVE: To explore the effects of PR-fampridine on different aspects of walking function and to identify associated gait modifications in subjects with MS. METHODS: In this prospective, randomized, placebo-controlled, double-blind, phase II study (FAMPKIN; clinicaltrials.gov, NCT01576354), subjects received a 6-week course of oral placebo or PR-fampridine treatment (10 mg, twice daily) before crossing over. Using 3D-motion-analysis, kinematic and kinetic parameters were assessed during treadmill walking (primary endpoint). Clinical outcome measures included T25FW, 6-minute walk test (6MWT), and balance scales. Physical activity in everyday life was measured with an accelerometer device. RESULTS: Data from 55 patients were suitable for analysis. Seventeen subjects were timed-walk responders under PR-fampridine. For the total study population and for responders, a significant increase in walking speed (T25FW) and distance (6MWT) was observed. Gait pattern changes were found at the single-subject level and correlated with improvements in the T25FW and 6MWT. Physical activity was increased in responders. CONCLUSION:PR-fampridine improves walking speed, endurance, and everyday physical activity in a subset of subjects with MS and leads to individual modifications of the gait pattern.
RCT Entities:
BACKGROUND: Prolonged-release fampridine (PR-fampridine, 4-aminopyridine) increases walking speed in the timed 25-foot walk test (T25FW) in some patients (timed-walk responders) with multiple sclerosis (MS). OBJECTIVE: To explore the effects of PR-fampridine on different aspects of walking function and to identify associated gait modifications in subjects with MS. METHODS: In this prospective, randomized, placebo-controlled, double-blind, phase II study (FAMPKIN; clinicaltrials.gov, NCT01576354), subjects received a 6-week course of oral placebo or PR-fampridine treatment (10 mg, twice daily) before crossing over. Using 3D-motion-analysis, kinematic and kinetic parameters were assessed during treadmill walking (primary endpoint). Clinical outcome measures included T25FW, 6-minute walk test (6MWT), and balance scales. Physical activity in everyday life was measured with an accelerometer device. RESULTS: Data from 55 patients were suitable for analysis. Seventeen subjects were timed-walk responders under PR-fampridine. For the total study population and for responders, a significant increase in walking speed (T25FW) and distance (6MWT) was observed. Gait pattern changes were found at the single-subject level and correlated with improvements in the T25FW and 6MWT. Physical activity was increased in responders. CONCLUSION:PR-fampridine improves walking speed, endurance, and everyday physical activity in a subset of subjects with MS and leads to individual modifications of the gait pattern.
Authors: Sarah D Broicher; Linard Filli; Olivia Geisseler; Nicole Germann; Björn Zörner; P Brugger; M Linnebank Journal: J Neurol Date: 2018-02-20 Impact factor: 4.849
Authors: Linard Filli; Tabea Sutter; Christopher S Easthope; Tim Killeen; Christian Meyer; Katja Reuter; Lilla Lörincz; Marc Bolliger; Michael Weller; Armin Curt; Dominik Straumann; Michael Linnebank; Björn Zörner Journal: Sci Rep Date: 2018-03-21 Impact factor: 4.379