Document Detail

A phase 3 trial of extended release oral dalfampridine in multiple sclerosis.
MedLine Citation:
PMID:  20976768     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: A previous phase 3 study showed significant improvement in walking ability in multiple sclerosis (MS) patients treated with oral, extended-release dalfampridine (4-aminopyridine) 10mg twice daily. The current study was designed to confirm efficacy and further define safety and pharmacodynamics. METHODS: This was a 39-center, double-blind trial in patients with definite MS of any course type. Participants were randomized to 9 weeks of treatment with dalfampridine (10mg twice daily; n = 120) or placebo (n = 119). Response was defined as consistent improvement on the Timed 25-Foot Walk, with percentage of timed walk responders (TWRs) in each treatment group as the primary outcome. The last on-treatment visit provided data from 8 to 12 hours postdose, to examine maintenance of effect. RESULTS: One patient from each group was excluded from the modified Intention to Treat population. The proportion of TWRs was higher in the dalfampridine group (51/119 or 42.9%) compared to the placebo group (11/118 or 9.3%, p < 0.0001). The average improvement in walking speed among dalfampridine-treated TWRs during the 8-week efficacy evaluation period was 24.7% from baseline (95% confidence interval, 21.0-28.4%); the mean improvement at the last on-treatment visit was 25.7%, showing maintenance of effect over the interdosing period. There were no new safety findings. INTERPRETATION: This interventional study provides class 1 evidence that dalfampridine extended-release tablets produce clinically meaningful improvement in walking ability in a subset of people with MS, with the effect maintained between doses.
Andrew D Goodman; Theodore R Brown; Keith R Edwards; Lauren B Krupp; Randall T Schapiro; Ron Cohen; Lawrence N Marinucci; Andrew R Blight;
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Annals of neurology     Volume:  68     ISSN:  1531-8249     ISO Abbreviation:  Ann. Neurol.     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-10-26     Completed Date:  2010-11-12     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7707449     Medline TA:  Ann Neurol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  494-502     Citation Subset:  IM    
Department of Neurology, University of Rochester Medical Center, Rochester, NY 14642, USA.
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MeSH Terms
4-Aminopyridine / blood,  therapeutic use*
Disability Evaluation
Double-Blind Method
Drug Administration Schedule
Middle Aged
Movement Disorders / drug therapy,  etiology
Multiple Sclerosis / blood,  complications,  drug therapy*
Potassium Channel Blockers / blood,  therapeutic use*
Walking / physiology
Young Adult
Reg. No./Substance:
0/Potassium Channel Blockers; 504-24-5/4-Aminopyridine
Mark Agius / ; Barry G W Arnason / ; Francois A Bethoux / ; Christopher T Bever / ; Theodore R Brown / ; Ann Camac / ; Joanna A Cooper / ; Warren F Chumley / ; Anne Cross / ; Dennis W Dietrich / ; Ralph T Dunnigan / ; Keith Edwards / ; Mitchell Freedman / ; Jeffrey S Gitt / ; Machteld Hillen / ; Douglas R Jeffery / ; Norman J Kachuck / ; Bhupendra O Khatri / ; Michael D Kaufman / ; Omar Khan / ; Kirin Kresa-Reahl / ; Lauren B Krupp / ; Thomas P Leist / ; Fred D Lublin / ; Michele K Mass / ; David Mattson / ; Daniel McGowan / ; Steven Moon / ; Colleen O'Connell / ; Joel J Oger / ; Hillel Panitch / ; Mary A Picone / ; Jana Preiningerova / ; Kottil W Rammohan / ; Randall T Schapiro / ; Steven R Schwid / ; Christine Short / ; Ben W Thrower / ; Mark Tullman / ; Bianca Weinstock-Guttman / ; Daniel R Wynn / ; Timothy L Vollmer /

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