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This Article Figures Only Full Text Full Text (PDF) Data Supplement All Versions of this Article: 01.wnl.0000326213.89576.0ev1 71/15/1134    most recent Correspondence: Submit a response Alert me when this article is cited Alert me when Correspondence are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Google Scholar Articles by Goodman, A. D. PubMed PubMed Citation Articles by Goodman, A. D. Related Collections All Clinical Neurology Clinical trials Randomized controlled (CONSORT agreement) Clinical trials Methodology/study design Multiple sclerosis Related Article

Dose comparison trial of sustained-release fampridine in multiple sclerosis

From the Department of Neurology (A.D.G., S.R.S.), University of Rochester, NY; Department of Neurology (T.R.B.), Evergreen Hospital Medical Center, Seattle, WA; Department of Neurology (J.A.C.), Cleveland Clinic Foundation, OH; Department of Neurology (L.K.), Stony Brook University Hospital, NY; Minneapolis Clinic of Neurology (R.S.), MN; and Acorda Therapeutics, Inc. (R.C., L.N.M., A.R.B.), Hawthorne, NY.

Address correspondence and reprint requests to Dr. Andrew D. Goodman, Multiple Sclerosis Center, Chief Neuroimmunology Unit, Department of Neurology, University of Rochester Medical Center, 601 Elmwood Ave., Room 6-8521, Box 605, Rochester, NY 14642 andrew_goodman{at}urmc.rochester.edu

Objective: To examine the efficacy and safety of three different doses of sustained-release fampridine in people with multiple sclerosis (MS).

Method: This multicenter, randomized, double-blind, placebo-controlled, parallel-group study recruited 206 participants at 24 centers in the United States and Canada. After a single-blind, 2-week placebo run-in, participants were randomly assigned to receive fampridine (10, 15, or 20 mg twice daily) or placebo for 15 weeks. The primary efficacy variable was percent change in walking speed based on the timed 25-foot walk.

Results: Trends for increased walking speed were consistent across dose groups vs placebo, but not significant, on the prospective analysis. An increase from baseline in lower extremity strength during the 12-week stable-dose period was seen in the groups receiving 10- and 15-mg doses, compared with placebo (p = 0.018 and 0.003). There were no significant changes in other secondary assessments. Post hoc analysis revealed subsets of participants in each dose group with walking speeds during the treatment period that were consistently faster than during the nontreatment period. There were significantly more "consistent responders" in the drug-treated groups than in the placebo group (36.7% compared with 8.5%). Consistent responders showed significantly greater improvement in self-assessed ambulation on the 12-Item MS Walking Scale than did nonresponders. Fampridine was generally well tolerated. Severe and serious adverse events were more frequent at the highest dose.

Conclusions: This phase 2 study suggests that a subgroup of patients, when treated with fampridine, experiences a clinically relevant improvement in walking ability, which is sustained for at least 14 weeks.

Abbreviations: 9HPT = Nine-Hole Peg Test; AE = adverse event; ANOVA = analysis of variance; CGI = Clinician Global Impression; CMH = Cochran–Mantel–Haenszel; CONSORT = Consolidated Standards of Reporting Trials; ITT = intention to treat; LEMMT = Lower Extremity Manual Muscle Test; MS = multiple sclerosis; MSFC = Multiple Sclerosis Functional Composite; MSQLI = Multiple Sclerosis Quality of Life Inventory; MSWS-12 = 12-Item Multiple Sclerosis Walking Scale; PASAT = Paced Auditory Serial Addition Test; SAE = serious adverse event; SGI = Subject Global Impression; T25FW = Timed 25-Foot Walk test.

Supplemental data at www.neurology.org

Editorial, page 1130

e-Pub ahead of print on July 30, 2008, at www.neurology.org.

*See the appendix for a list of the Fampridine MS-F202 Study Group investigators.

Disclosure: A.D.G., J.A.C., R.S., and T.R.B. have been consultants to Acorda Therapeutics. R.C., A.R.B., and L.N.M. are full-time employees of and have stock holdings in Acorda Therapeutics.

Received July 22, 2007. Accepted in final form March 3, 2008.

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Fampridine for MS responders: Clinically relevant or hypothesis generating?

Richard J. Kryscio
Neurology 2008 71: 1130-1131. [Full Text] [PDF]

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				R. J. Kryscio Fampridine for MS responders: Clinically relevant or hypothesis generating? Neurology, October 7, 2008; 71(15): 1130 - 1131. [Full Text] [PDF]

				A. R Korenke, M. P Rivey, and D. R Allington Sustained-Release Fampridine for Symptomatic Treatment of Multiple Sclerosis Ann. Pharmacother., October 1, 2008; 42(10): 1458 - 1465. [Abstract] [Full Text] [PDF]