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Erschienen in: Neurological Sciences 1/2023

12.09.2022 | Clinical Trial article

Fampridine in multiple sclerosis patients with acute phase of cervical transverse myelitis: a double-blind, randomized placebo-controlled trial

verfasst von: Ali Amini Harandi, Hossein Pakdaman, Faezeh Karamiani, Faezeh Mohammadi, Siavash Shirzadeh Barough, Fatemeh Siavoshi, Saba Ilkhani, Mohammadali Sahraian

Erschienen in: Neurological Sciences | Ausgabe 1/2023

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Abstract

Background

Fampridine is a potassium channel blocker drug used to improve walking ability in patients with multiple sclerosis (MS). We evaluated the effect of fampridine in patients with MS in the acute phase of transverse myelitis.

Methods

In a randomized, placebo-controlled trial, 30 patients who had their first episode of cervical myelitis with quadriparesis presentation, with the final diagnosis of MS, were randomly divided into two equal groups. The intervention group received intravenous methylprednisolone (IVMP) for 7 days plus fampridine. The placebo group received IVMP for 7 days plus placebo. To compare the treatment results, we compared the Barthel index (BI) scores of the groups at the start of the trial and the 21st day after the start of treatment.

Results

There was no significant difference in baseline characteristics between the intervention and placebo groups in terms of mean age, sex, and mean admission BI (p > 0.05). Mean (SD) admission BI in placebo and intervention groups was 27.20 (7.341) and 27.87(5.78), respectively (p = 0.784). The measured mean (SD) BI after treatment was 48.73 (15.54) in the placebo and 64.93 (11.81) in the intervention group (p = 0.003) after 3 weeks.

Conclusion

Using fampridine plus IVMP in the acute phase of transverse myelitis in MS patients improved the disease’s symptoms and increased the daily activity ability of patients.
Literatur
1.
Zurück zum Zitat Oh J, Vidal-Jordana A, Montalban X (2018) Multiple sclerosis: clinical aspects. Curr Opin Neurol 31(6):752–759CrossRef Oh J, Vidal-Jordana A, Montalban X (2018) Multiple sclerosis: clinical aspects. Curr Opin Neurol 31(6):752–759CrossRef
2.
Zurück zum Zitat West TW (2013) Transverse myelitis–a review of the presentation, diagnosis, and initial management. Discov Med 16(88):167–177 West TW (2013) Transverse myelitis–a review of the presentation, diagnosis, and initial management. Discov Med 16(88):167–177
3.
Zurück zum Zitat Ciccarelli O, Cohen JA, Reingold SC, Weinshenker BG (2019) Spinal cord involvement in multiple sclerosis and neuromyelitis optica spectrum disorders. Lancet Neurol 18(2):185–197CrossRef Ciccarelli O, Cohen JA, Reingold SC, Weinshenker BG (2019) Spinal cord involvement in multiple sclerosis and neuromyelitis optica spectrum disorders. Lancet Neurol 18(2):185–197CrossRef
4.
Zurück zum Zitat Ohashi T (2014) Short-term high-dose intravenous methylprednisolone therapy. Nihon rinsho Jpn J Clin Med 72(11):1995–1998 Ohashi T (2014) Short-term high-dose intravenous methylprednisolone therapy. Nihon rinsho Jpn J Clin Med 72(11):1995–1998
5.
Zurück zum Zitat Costello J, Njue A, Lyall M, Heyes A, Mahler N, Philbin M et al (2019) Efficacy, safety, and quality-of-life of treatments for acute relapses of multiple sclerosis: results from a literature review of randomized controlled trials. Degener Neurol Neuromuscul Dis 9:55–78 Costello J, Njue A, Lyall M, Heyes A, Mahler N, Philbin M et al (2019) Efficacy, safety, and quality-of-life of treatments for acute relapses of multiple sclerosis: results from a literature review of randomized controlled trials. Degener Neurol Neuromuscul Dis 9:55–78
6.
Zurück zum Zitat Sorensen PS, Haas J, Sellebjerg F, Olsson T, Ravnborg M (2004) IV immunoglobulins as add-on treatment to methylprednisolone for acute relapses in MS. Neurology 63(11):2028–2033CrossRef Sorensen PS, Haas J, Sellebjerg F, Olsson T, Ravnborg M (2004) IV immunoglobulins as add-on treatment to methylprednisolone for acute relapses in MS. Neurology 63(11):2028–2033CrossRef
7.
Zurück zum Zitat Visser LH, Beekman R, Tijssen CC, Uitdehaag BM, Lee ML, Movig KL et al (2004) A randomized, double-blind, placebo-controlled pilot study of i.v. immune globulins in combination with i.v. methylprednisolone in the treatment of relapses in patients with MS. Mult Scler (Houndmills, Basingstoke, England) 10(1):89–91 Visser LH, Beekman R, Tijssen CC, Uitdehaag BM, Lee ML, Movig KL et al (2004) A randomized, double-blind, placebo-controlled pilot study of i.v. immune globulins in combination with i.v. methylprednisolone in the treatment of relapses in patients with MS. Mult Scler (Houndmills, Basingstoke, England) 10(1):89–91
8.
Zurück zum Zitat Valet M, Quoilin M, Lejeune T, Stoquart G, Van Pesch V, El Sankari S et al (2019) Effects of fampridine in people with multiple sclerosis: a systematic review and meta-analysis. CNS Drugs 33(11):1087–1099CrossRef Valet M, Quoilin M, Lejeune T, Stoquart G, Van Pesch V, El Sankari S et al (2019) Effects of fampridine in people with multiple sclerosis: a systematic review and meta-analysis. CNS Drugs 33(11):1087–1099CrossRef
9.
Zurück zum Zitat Filli L, Zörner B, Kapitza S, Reuter K, Lörincz L, Weller D, Sutter T, Killeen T, Gruber P, Petersen JA, Weller M (2017) Monitoring long-term efficacy of fampridine in gait-impaired patients with multiple sclerosis. Neurology 88(9):832–841CrossRef Filli L, Zörner B, Kapitza S, Reuter K, Lörincz L, Weller D, Sutter T, Killeen T, Gruber P, Petersen JA, Weller M (2017) Monitoring long-term efficacy of fampridine in gait-impaired patients with multiple sclerosis. Neurology 88(9):832–841CrossRef
10.
Zurück zum Zitat Marion S, Leonid C, Belinda B, Joanne D, Elise H, Leeanne C et al (2020) Effects of modified-release fampridine on upper limb impairment in patients with multiple sclerosis. Mult Scler Relat Disord 40:101971CrossRef Marion S, Leonid C, Belinda B, Joanne D, Elise H, Leeanne C et al (2020) Effects of modified-release fampridine on upper limb impairment in patients with multiple sclerosis. Mult Scler Relat Disord 40:101971CrossRef
11.
Zurück zum Zitat Sagawa Y, Watelain E, Moulin T, Decavel P (2018) No effect of fampridine on real-life physical activity in people with multiple sclerosis. Ann Phys Rehabil Med 61(2):105–107CrossRef Sagawa Y, Watelain E, Moulin T, Decavel P (2018) No effect of fampridine on real-life physical activity in people with multiple sclerosis. Ann Phys Rehabil Med 61(2):105–107CrossRef
12.
Zurück zum Zitat Chen L, Li J, Guo Z, Liao S, Jiang L (2013) Prognostic indicators of acute transverse myelitis in 39 children. Pediatr Neurol 49(6):397–400CrossRef Chen L, Li J, Guo Z, Liao S, Jiang L (2013) Prognostic indicators of acute transverse myelitis in 39 children. Pediatr Neurol 49(6):397–400CrossRef
13.
Zurück zum Zitat Prodinger B, O’Connor RJ, Stucki G, Tennant A (2017) Establishing score equivalence of the Functional Independence Measure motor scale and the Barthel Index, utilising the International Classification of Functioning, Disability and Health and Rasch measurement theory. J Rehabil Med 49(5):416–422CrossRef Prodinger B, O’Connor RJ, Stucki G, Tennant A (2017) Establishing score equivalence of the Functional Independence Measure motor scale and the Barthel Index, utilising the International Classification of Functioning, Disability and Health and Rasch measurement theory. J Rehabil Med 49(5):416–422CrossRef
14.
Zurück zum Zitat Mahoney FI (1965) Functional evaluation: The Barthel index. Md State Med J 4(2):61–5 Mahoney FI (1965) Functional evaluation: The Barthel index. Md State Med J 4(2):61–5
15.
Zurück zum Zitat Tramontano M, Martino Cinnera A, Manzari L, Tozzi FF, Caltagirone C, Morone G, Pompa A, Grasso MG (2018) Vestibular rehabilitation has positive effects on balance, fatigue and activities of daily living in highly disabled multiple sclerosis people: a preliminary randomized controlled trial. Restor Neurol Neurosci 36(6):709–718 Tramontano M, Martino Cinnera A, Manzari L, Tozzi FF, Caltagirone C, Morone G, Pompa A, Grasso MG (2018) Vestibular rehabilitation has positive effects on balance, fatigue and activities of daily living in highly disabled multiple sclerosis people: a preliminary randomized controlled trial. Restor Neurol Neurosci 36(6):709–718
16.
Zurück zum Zitat Noordzij M, Tripepi G, Dekker FW, Zoccali C, Tanck MW, Jager KJ (2010) Sample size calculations: basic principles and common pitfalls. Nephrol Dial Transplant 25(5):1388–1393CrossRef Noordzij M, Tripepi G, Dekker FW, Zoccali C, Tanck MW, Jager KJ (2010) Sample size calculations: basic principles and common pitfalls. Nephrol Dial Transplant 25(5):1388–1393CrossRef
17.
Zurück zum Zitat Pickering H, Murray J, Lin CS, Cormack C, Martin A, Kiernan MC, Krishnan AV (2017) Fampridine treatment and walking distance in multiple sclerosis: a randomised controlled trial. Clin Neurophysiol 128(1):93–99CrossRef Pickering H, Murray J, Lin CS, Cormack C, Martin A, Kiernan MC, Krishnan AV (2017) Fampridine treatment and walking distance in multiple sclerosis: a randomised controlled trial. Clin Neurophysiol 128(1):93–99CrossRef
18.
Zurück zum Zitat Hupperts R, Lycke J, Short C, Gasperini C, McNeill M, Medori R, Tofil-Kaluza A, Hovenden M, Mehta LR, Elkins J (2016) Prolonged-release fampridine and walking and balance in MS: randomised controlled MOBILE trial. Mult Scler J 22(2):212–221CrossRef Hupperts R, Lycke J, Short C, Gasperini C, McNeill M, Medori R, Tofil-Kaluza A, Hovenden M, Mehta LR, Elkins J (2016) Prolonged-release fampridine and walking and balance in MS: randomised controlled MOBILE trial. Mult Scler J 22(2):212–221CrossRef
19.
Zurück zum Zitat Zörner B, Filli L, Reuter K, Kapitza S, Lörincz L, Sutter T, Weller D, Farkas M, Easthope CS, Czaplinski A, Weller M (2016) Prolonged-release fampridine in multiple sclerosis: improved ambulation effected by changes in walking pattern. Mult Scler J 22(11):1463–1475CrossRef Zörner B, Filli L, Reuter K, Kapitza S, Lörincz L, Sutter T, Weller D, Farkas M, Easthope CS, Czaplinski A, Weller M (2016) Prolonged-release fampridine in multiple sclerosis: improved ambulation effected by changes in walking pattern. Mult Scler J 22(11):1463–1475CrossRef
20.
Zurück zum Zitat Pavsic K, Pelicon K, Ledinek AH, Sega S (2015) Short-term impact of fampridine on motor and cognitive functions, mood and quality of life among multiple sclerosis patients. Clin Neurol Neurosurg 1(139):35–40CrossRef Pavsic K, Pelicon K, Ledinek AH, Sega S (2015) Short-term impact of fampridine on motor and cognitive functions, mood and quality of life among multiple sclerosis patients. Clin Neurol Neurosurg 1(139):35–40CrossRef
21.
Zurück zum Zitat Savin Z, Lejbkowicz I, Glass-Marmor L, Lavi I, Rosenblum S, Miller A (2016) Effect of fampridine-PR (prolonged released 4-aminopyridine) on the manual functions of patients with Multiple Sclerosis. J Neurol Sci 15(360):102–109CrossRef Savin Z, Lejbkowicz I, Glass-Marmor L, Lavi I, Rosenblum S, Miller A (2016) Effect of fampridine-PR (prolonged released 4-aminopyridine) on the manual functions of patients with Multiple Sclerosis. J Neurol Sci 15(360):102–109CrossRef
Metadaten
Titel
Fampridine in multiple sclerosis patients with acute phase of cervical transverse myelitis: a double-blind, randomized placebo-controlled trial
verfasst von
Ali Amini Harandi
Hossein Pakdaman
Faezeh Karamiani
Faezeh Mohammadi
Siavash Shirzadeh Barough
Fatemeh Siavoshi
Saba Ilkhani
Mohammadali Sahraian
Publikationsdatum
12.09.2022
Verlag
Springer International Publishing
Erschienen in
Neurological Sciences / Ausgabe 1/2023
Print ISSN: 1590-1874
Elektronische ISSN: 1590-3478
DOI
https://doi.org/10.1007/s10072-022-06380-6

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