Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-Sustained Release (SR) in Canadian Participants With Multiple Sclerosis Who Participated in Acorda Extension Trials.
Completed
Acorda Therapeutics
Phase 3
2010-12-01
The primary objective of the study is to evaluate the long-term safety and tolerability of
BIIB041 (fampridine-sustained release (SR)) treatment in Canadian participants with multiple
sclerosis (MS) who previously participated in the registrational and extension studies
conducted by Acorda. Those studies include NCT00654927 (MS-F202EXT), NCT00648908 (MS-F203EXT)
and NCT00649792 (MS-F204EXT).
Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-Sustained Release (SR) in Canadian Participants With Multiple Sclerosis Who Participated in Acorda Extension Trials.
Completed
Biogen
Phase 3
2010-12-01
The primary objective of the study is to evaluate the long-term safety and tolerability of
BIIB041 (fampridine-sustained release (SR)) treatment in Canadian participants with multiple
sclerosis (MS) who previously participated in the registrational and extension studies
conducted by Acorda. Those studies include NCT00654927 (MS-F202EXT), NCT00648908 (MS-F203EXT)
and NCT00649792 (MS-F204EXT).
Fifty subjects will be enrolled in this Phase II, investigator-initiated, randomized and
blinded cross-over trial of dalfampridine of 8 weeks duration The study will test the
hypothesis that dalfampridine, when administered to subjects with incomplete visual recovery
after optic neuritis from MS, will result in symptomatic improvement in visual function. The
study will consist of one screening/baseline visit, one visit during treatment with active
drug, and one visit on placebo. After the baseline visit, subjects will be randomly assigned
to receive study medication or placebo for the first three weeks, followed by a two week
wash-out, and then treatment reallocation for the latter three weeks.
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