Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-SR in Canadian Subjects With Multiple Sclerosis Who Participated in Acorda Extension Trials.

This is an open label study to evaluate the safety and tolerability of long term treatment with fampridine-SR 10 mg BID for up to 27 additional months or until availability of commercial product (whichever sooner) following treatment in Acorda sponsored Studies (MS-F202EXT, MS-F203EXT, and MS-F204EXT) and also the current recommendations of commercially available dalfampridine-ER in the US.

Primary Objectives The primary objective of the study is to evaluate the long-term safety and tolerability of fampridine-SR treatment in Canadian subjects with MS who previously participated in the registrational and extension studies conducted by Acorda.

Endpoints The primary endpoints include the safety parameters: adverse events (AEs) and serious adverse events (SAEs), as well as changes in vital signs and clinical laboratory assessments.

Study Location: Canada

Number of planned subjects: Approximately 38 subjects

Study Population: This study will be conducted in Canadian subjects with MS who participated in one of Acorda-sponsored studies (MS-F202EXT, MS-F203EXT, and MS-F204EXT).

Treatments Groups: All subjects will receive fampridine-SR

Duration of Treatment and Follow-up: The duration of the study treatment with fampridine-SR will be up to 27 months or until fampridine-SR becomes commercially available, whichever comes first. The Follow-up period will be 1 month after subjects' last dose of study treatment.

Key Inclusion Criteria :

1. Previously enrolled in 1 of the 3 Acorda-sponsored studies (MS-F202EXT, MS-F203EXT, and MS-F204EXT) and continuing to receive fampridine-SR.
2. Willing to comply with the required scheduling and assessments of the protocol.
3. Female subjects of childbearing potential, regardless of sexual activity, must have a negative urine pregnancy test, and must practice effective contraception during the study and be willing and able to continue contraception for 1 month after their last dose of study treatment.

Key Exclusion Criteria:

1. Discontinued prematurely from the preceding study ((MS-F202EXT, MS-F203EXT, or MS-F204EXT).
2. Any prior history of seizure, epilepsy, or other convulsive disorder.
3. Any clinically significant abnormal laboratory values.
4. New history of moderate or severe renal impairment.
5. New history of angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator.
6. Any significant change in overall health that would preclude subject's participation in the study, in the opinion of the Investigator.
7. Known allergy to pyridine-containing substances or any of the inactive ingredients of the fampridine-SR tablet
8. Received an investigational drug, except fampridine-SR under the preceding study (MS-F202EXT, MS-F203EXT, or MS-F204EXT), within the last 30 days, or the subject is scheduled to enroll in an investigational drug at any time during the study.
9. A history of drug or alcohol abuse within the past year.
10. Treatment with other forms of fampridine or 4-AP (e.g., compounded formulation of 4-AP) or 3,4-diaminopyridine (3,4-DAP).