Contributions
Abstract: P901
Type: Poster
Abstract Category: Clinical aspects of MS - 7 MS symptoms
Background: Upper limb (UL) dysfunction is common in progressive multiple sclerosis (MS) with significant impact on functional independence. Fampridine-PR has been shown to improve walking speed in progressive MS. It blocks voltage-gated K+ channels on demyelinated axons, enhancing neuromuscular transmission. We propose it should also result in improvements in other domains, including UL function.
Aims: To assess the effect of fampridine-PR on UL function in patients with progressive MS.
Methods: A crossover, randomized, double blind, placebo-controlled trial design was developed. Patients with progressive MS and objective UL dysfunction, defined by 9-hole peg test (9-HPT) time between 15-90 seconds were recruited from a tertiary referral MS clinic. Study duration was 22 weeks with two 8-week treatment blocks separated by a 2-week wash out period and 2-week follow-up visit. Primary outcome measures were change in UL function assessed by 9-HPT and Jebson Taylor Hand Function Test (JTT) on treatment compared with placebo.
Results: 62 patients, mean age 52 years (range 29 - 69), mean EDSS 6.0, completed the study. 60% were female, and 31% had primary progressive MS. Mean disease duration was 17 years (range 0 - 49). Responders were defined as having a >20% improvement in 9-HPT, or JTT. Lower limb responders had a >20% improvement in timed 25-foot walk (T25FW).
For dominant hand JTT total scores; 12 participants on treatment responded compared with 4 on placebo, a significant positive effect of treatment on responder rates (p=0.02), with a trend towards significance in overall mean times on treatment compared with placebo (p=0.09). For 9-HPT, 5 patients responded in the treatment group and 2 on placebo, with a significant positive effect of treatment on responder rates (p=0.035), but no significant difference in mean times (p=0.583). There was no significant difference in mean times (p=0.4), or responder rates for T25FW between groups. Responders were significantly younger than non-responders, mean age 46 years (p=0.04). There was no difference in EDSS in responders (mean EDSS 6.0) to non-responders (p=0.9).
Discussion: A significant improvement in UL function was seen in 22% of patients in response to treatment with fampridine-PR. This supports our hypothesis that its effects are not limited to lower limb function in a subset of patients. A multi-domain outcome measure, JTT, was more sensitive at assessing response compared with the 9-HPT.
Disclosure:
N McNicholas has received a Newman fellowship sponsored by Biogen.
K O'Connell has received travel and educational grants from Biogen, Novartis, Abvie, Teva and Merck Serono.
SM Yap has received a Newman fellowship sponsored by Novartis.
N Tubridy has received, on behalf of the Department of Neurology, St Vincent's University Hospital, educational and re- search grants from Novartis, Biogen, Teva and Bayer.
M Hutchinson has received speaker's honoraria from Biogen, Bayer -Schering, Merck Serono and Novartis and receives research grants from Dystonia Ireland, the Health Research Board of Ireland (CSA-2012/5) and the Irish Institute of Clinical Neuroscience.
C McGuigan has received honoraria, participated in advisory boards and/or received research funding from Biogen, Merck Serono, Novartis, Roche, Genzyme and Bayer. G O'Boyle has no disclosures, S Cox has no disclosures, D Sharma has no disclosures, S Jordan has no disclosures, L Buckley has no disclosures, C Muldowney has no disclosures, C Donnelly has no disclosures, A Sheik has no disclosures, C Walsh has no disclosures.
This study was sponsored by University College Dublin under the guidance of Dr Peter Doran. This trial was funded from an education grant provided by Biogen. We acknowledge the assistance of the following in conducting this study: R Byrne, B O'Loughlin, M Duggan.
Abstract: P901
Type: Poster
Abstract Category: Clinical aspects of MS - 7 MS symptoms
Background: Upper limb (UL) dysfunction is common in progressive multiple sclerosis (MS) with significant impact on functional independence. Fampridine-PR has been shown to improve walking speed in progressive MS. It blocks voltage-gated K+ channels on demyelinated axons, enhancing neuromuscular transmission. We propose it should also result in improvements in other domains, including UL function.
Aims: To assess the effect of fampridine-PR on UL function in patients with progressive MS.
Methods: A crossover, randomized, double blind, placebo-controlled trial design was developed. Patients with progressive MS and objective UL dysfunction, defined by 9-hole peg test (9-HPT) time between 15-90 seconds were recruited from a tertiary referral MS clinic. Study duration was 22 weeks with two 8-week treatment blocks separated by a 2-week wash out period and 2-week follow-up visit. Primary outcome measures were change in UL function assessed by 9-HPT and Jebson Taylor Hand Function Test (JTT) on treatment compared with placebo.
Results: 62 patients, mean age 52 years (range 29 - 69), mean EDSS 6.0, completed the study. 60% were female, and 31% had primary progressive MS. Mean disease duration was 17 years (range 0 - 49). Responders were defined as having a >20% improvement in 9-HPT, or JTT. Lower limb responders had a >20% improvement in timed 25-foot walk (T25FW).
For dominant hand JTT total scores; 12 participants on treatment responded compared with 4 on placebo, a significant positive effect of treatment on responder rates (p=0.02), with a trend towards significance in overall mean times on treatment compared with placebo (p=0.09). For 9-HPT, 5 patients responded in the treatment group and 2 on placebo, with a significant positive effect of treatment on responder rates (p=0.035), but no significant difference in mean times (p=0.583). There was no significant difference in mean times (p=0.4), or responder rates for T25FW between groups. Responders were significantly younger than non-responders, mean age 46 years (p=0.04). There was no difference in EDSS in responders (mean EDSS 6.0) to non-responders (p=0.9).
Discussion: A significant improvement in UL function was seen in 22% of patients in response to treatment with fampridine-PR. This supports our hypothesis that its effects are not limited to lower limb function in a subset of patients. A multi-domain outcome measure, JTT, was more sensitive at assessing response compared with the 9-HPT.
Disclosure:
N McNicholas has received a Newman fellowship sponsored by Biogen.
K O'Connell has received travel and educational grants from Biogen, Novartis, Abvie, Teva and Merck Serono.
SM Yap has received a Newman fellowship sponsored by Novartis.
N Tubridy has received, on behalf of the Department of Neurology, St Vincent's University Hospital, educational and re- search grants from Novartis, Biogen, Teva and Bayer.
M Hutchinson has received speaker's honoraria from Biogen, Bayer -Schering, Merck Serono and Novartis and receives research grants from Dystonia Ireland, the Health Research Board of Ireland (CSA-2012/5) and the Irish Institute of Clinical Neuroscience.
C McGuigan has received honoraria, participated in advisory boards and/or received research funding from Biogen, Merck Serono, Novartis, Roche, Genzyme and Bayer. G O'Boyle has no disclosures, S Cox has no disclosures, D Sharma has no disclosures, S Jordan has no disclosures, L Buckley has no disclosures, C Muldowney has no disclosures, C Donnelly has no disclosures, A Sheik has no disclosures, C Walsh has no disclosures.
This study was sponsored by University College Dublin under the guidance of Dr Peter Doran. This trial was funded from an education grant provided by Biogen. We acknowledge the assistance of the following in conducting this study: R Byrne, B O'Loughlin, M Duggan.