At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 214 enrolled
Drug / intervention
Fampridine-SRdrug
Likely dose
Fampridine-SR 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 3 Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial
In Brief
A Phase 3 clinical trial evaluating Fampridine-SR for Multiple Sclerosis. Completed, enrolled 214 participants across 42 sites in 2 countries.
Detailed Summary
The purpose of the study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months in patients who previously participated in the MS-F204 study or until it becomes commercially available, whichever comes first.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2007
First PostedApr 2008
Primary CompletionJan 2011
Study CompletionApr 2011
TodayJul 2026
First PostedApr 1, 2008
Enrollment StartAug 1, 2007
Primary CompletionJan 1, 2011
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 18.3 years ago
Interventions
Fampridine-SRdrug
Tablets, 10 mg, BID (twice daily)