Dalfampridine sustained-release for symptomatic improvement of walking speed in patients with multiple sclerosis

Core Evidence

Volumn 5, Issue , 2010, Pages 107-112

  Jeffery, Douglas R ^a   Pharr, Emily Poole ^b  

^a MS Center at Advance Neurology   (United States)

^b WAKE FOREST UNIVERSITY HEALTH SCIENCES   (United States)

Author keywords

Ambulation; Clinical trials; Dalfampridine SR; Multiple sclerosis; Safety; Walking speed

Indexed keywords

4 AMINOPYRIDINE DERIVATIVE; CYTOCHROME P450 2E1; DALFAMPRIDINE; PLACEBO; POTASSIUM CHANNEL BLOCKING AGENT; UNCLASSIFIED DRUG;

ASTHENIA; BALANCE IMPAIRMENT; CREATININE CLEARANCE; DISEASE SEVERITY; DIZZINESS; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG HALF LIFE; DRUG METABOLISM; DRUG TREATMENT FAILURE; ELECTROENCEPHALOGRAPHY; EPILEPTIC DISCHARGE; FATIGUE; FOOD AND DRUG ADMINISTRATION; HEADACHE; HUMAN; INSOMNIA; KIDNEY CLEARANCE; MOTOR PERFORMANCE; MULTIPLE SCLEROSIS; MUSCLE STRENGTH; OFF LABEL DRUG USE; OUTCOME ASSESSMENT; PARESTHESIA; PHASE 2 CLINICAL TRIAL (TOPIC); PLASMA PROTEIN BINDING; PNEUMONIA; RATING SCALE; RELAPSE; REMISSION; REVIEW; RISK BENEFIT ANALYSIS; SEIZURE; SUSTAINED DRUG RELEASE; THORAX PAIN; URINARY TRACT INFECTION; WALKING SPEED;

EID: 79959362216     PISSN: 15551741     EISSN: None     Source Type: Journal    
DOI: 10.2147/CE.S9046     Document Type: Review

References (20)

1. Noonan CW, Kathman SJ, White MC. Prevalence estimates for MS in the United States and evidence of an increasing trend for women. Neurology. 2002;58:136-138. (Pubitemid 34041953)
2. Noseworthy JH, Lucchinetti C, Rodriguez M, Weinshenker BG. Multiple sclerosis. N Engl J Med. 2000;343:938-952.
3. National Multiple Sclerosis Society. Loss of mobility found to impact quality of live and emotional and financial health of most people living with multiple sclerosis. Available at: http://www.nationalmssociety.org/news/news- detail/index.aspx?nid=199. Accessed 2009 Dec 8.
4. Herndon RM. Pathology and pathophysiology. In: Burks JS, Johnson KP, editors. Multiple Sclerosis: Diagnosis, Medical Management, and Rehabilitation. New York, NY: Demos Medical Publishing; 2000.
5. Sherratt RM, Bostock H, Sears TA. Effects of 4-aminopyridine on normal and demyelinated mammalian nerve fibres. Nature. 1980; 283: 570-572. (Pubitemid 10136031)
6. Bever CT, Young D, Anderson PA, et al. The effects of 4-aminopyridine in multiple sclerosis patients: Results of a randomized, placebo-controlled, double-blind, concentration-controlled, crossover trial. Neurology. 1994;44:1054-1059. (Pubitemid 24188176)
7. Schwid SR, Petrie MD, McDermott MP, et al. Quantitative assessment of sustained-release 4-aminopyridine for symptomatic treatment of multiple sclerosis. Neurology. 1997;48:817-821.
8. van Diemen HAM, Polman CH, van Dongen TM, et al. The effect of 4-aminopyridine on clinical signs in multiple sclerosis: A randomized, placebo-controlled, double-blind, cross-over study. Ann Neurol. 1992;32:123-130.
9. Stefoski D, Davis FA, Faut M, Schauf CL. 4-Aminopyridine improves clinical signs in multiple sclerosis. Ann Neurol. 1987;21:71-77. (Pubitemid 17004147)
10. Schwam E. Severe accidental overdose of 4-aminopyridine due to a compounding pharmacy error. Emerg Med. 2009 May 12. [Epub ahead of print].
11. Burton JM, Bell CM, Walker SE, O'Connor PW. 4-aminopyridine toxicity with unintentional overdose in four patients with multiple sclerosis. Neurology. 2008;71:1833-1834.
12. Hayes KC, Katz MA, Devane JG, et al. Pharmacokinetics of an immediate-release oral formulation of fampridine (4-aminopyridine) in normal subjects and patients with spinal cord injury. J Clin Pharmacol. 2003;43:379-385. (Pubitemid 36368779)
13. Smith W, Swan S, Marbury T, et al. Single-dose pharmacokinetics of sustained-release fampridine (fampridine-SR) in healthy volunteers and adults with renal impairment. J Clin Pharmacol. 2010;50:151-159.
14. Vollmer T, Henney HR. Pharmacokinetics and tolerability of single escalating doses of Fampridine sustained-release tablets in patients with multiple sclerosis: A phase I-II, open-label trial. Clin Ther. 2009;31:2206-2214.
15. Vollmer T, Blight AR, Henney HR. Steady-state pharmacokinetics and tolerability of orally administered fampridine sustained-release 10-mg tablets in patients with multiple sclerosis: A 2-week, open-label, follow-up study. Clin Ther. 2009;31:2215-2223.
16. Goodman AD, Brown TR, Cohen JA, et al. Dose comparison trial of sustained-release fampridine in multiple sclerosis. Neurology. 2008;71:1134-1141.
17. Goodman AD, Brown TR, Krupp LB, et al. Sustained-release oral fampridine in multiple sclerosis: A randomized, double-blind, controlled trial. Lancet. 2009;373:732-738.
18. Hobart JC, Riazi A, Lamping DL, et al. Measuring the impact of MS on walking ability: The 12-item MS walking scale (MSWS-12). Neurology. 2003;60:31-36. (Pubitemid 36070640)
19. Goodman AD, Schwid SR, Brown TR, et al. Sustained-release fampridine consistently improves walking speed and leg strength in multiple sclerosis: A phase 3 trial. Mult Scler. 2008;14:S295.
20. Schapiro R, Goodman AD, Brown T, Marinucci L, Cohen R, Blight A. Dalfampridine improves walking in MS patients: Pooled data from three clinical trials. 24th Annual Meeting of the Consortium of Multiple Sclerosis Centers. 2010;S114. Available from: http://mscare.org/cmsc/images/pdf/IJMSC-2010-May- Supp.pdf. Accessed 2010 Sep 30.