Abstract Details

Title FAME - FAmpyra Outcome Measure Study

Topic MS and Related Diseases

Presentation(s) P04 - (-)

Poster/Presentation
Number 098

Objective

Background BACKGROUND: Dalfampridine-SR improves walking speed in 35-43% of MS patients when measured by Timed 25 Foot Walk (T25FW). It also improves muscle strength in the lower extremities. The Six Spot Step Test (SSST) assesses ambulation with higher accuracy and sensitivity than T25FW.

Design/Methods DESIGN/METHODS: MS patients aged 18-60, EDSS 4-7. Double blind, parallel group RCT preceded by open label enrichment. Treatment with Dalfampridine-SR for four weeks commenced. SSST, T25FW, Sit-to-Stand Test, 9-Hole Peg Test and Symbol Digit Modalities Test performed on days 0 and 28 in both enrichment phase and intervention phase. Dynamometry performed in intervention phase. 40% showing greatest improvement on SSST entered the intervention phase. Participants in intervention phase randomized to Dalfampridine-SR or placebo for four weeks.

Results RESULTS: 120 participants enrolled in the enrichment phase. Mean percentage changes: SSST = -15.3 (SE=2.4, SD=21.1, 95% CI = -20.0 - -10.6); T25FW = -9.9 (SE=2.1, SD=18.6, 95% CI = -14.0 - -5.7); 9-HPT dominant = -6.3 (SE=1.4, SD=12.3, 95% CI = -9.0 - -3.5); 9-HPT non-dominant = -5.25 (SE=1.6, SD=13.8, 95% CI = -8.4 - -2.1; SDSMT = 6.5 (SE=1.8, SD=15.7, 95% CI = 3.0-10.0); Sit-to-Stand = -17.34 (SE=2.6, SD=22.4, 95% CI = -22.5 - -12.2); Difference between percentage changes in SSST and T25FW:; -5.5 (SE=2.1, SD=18.8, 95% CI = -9.6 - -1.3, p = 0.01); 67.4% respond to treatment (range of response rates 16.3%-47.4%.) 30% respond to three or more tests. Mean percentage improvement varies between 29.0% and 34.2%.

Conclusions CONCLUSIONS: Our results suggest that 67% respond to Dalfampridine-SR treatment and that a subset responds cognitively and in the upper extremity. These results are unblinded. Results from the blinded intervention phase will be available by March 2013.

Authors/Disclosures
Henrik Jensen PRESENTER	No disclosure on file
Ulrik Dalgas	Ulrik Dalgas has received personal compensation for serving as an employee of Roche. Ulrik Dalgas has received personal compensation for serving as an employee of Bristol Meyers Squibb.
	No disclosure on file
Egon Stenager, MD (MS-Clinic, SV-Sygehus Esbjerg)	No disclosure on file
	No disclosure on file

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