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.
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ClinicalTrials.gov Identifier: NCT01235221 |
Recruitment Status :
Completed
First Posted : November 5, 2010
Last Update Posted : July 4, 2014
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Condition or disease | Intervention/treatment | Phase |
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Multiple Sclerosis | Drug: BIIB041 (Fampridine-SR) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 38 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
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Experimental: BIIB041 (Fampridine-SR)
Participants take 10 mg sustained-release tablets of fampridine twice daily for up to 27 months or until the product is commercially available.
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Drug: BIIB041 (Fampridine-SR)
10 mg twice a day (BID) sustained-release (SR) tablets by mouth for up to 27 months (in addition to treatment in previous studies) or until the product is commercially available, whichever comes first. Doses of study treatment must be spaced at least 12 hours apart.
Other Names:
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- Adverse events (AEs) and serious adverse events (SAEs) as well as Changes in vital signs and clinical laboratory assessments [ Time Frame: From Screening (Day 0) to Termination (Month 27) ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria :
- Previously enrolled in 1 of the 3 Acorda-sponsored studies (MS-F202EXT, MS-F203EXT, and MS-F204EXT) and continuing to receive fampridine-SR.
- Willing to comply with the required scheduling and assessments of the protocol.
- 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:
- Discontinued prematurely from the preceding study ((MS-F202EXT, MS-F203EXT, or MS-F204EXT).
- Any prior history of seizure, epilepsy, or other convulsive disorder.
- Any clinically significant abnormal laboratory values.
- New history of moderate or severe renal impairment.
- New history of angina, uncontrolled hypertension, clinically significant cardiac arrhythmias, or any other clinically significant cardiovascular abnormality, as judged by the Investigator.
- Any significant change in overall health that would preclude subject's participation in the study, in the opinion of the Investigator.
- Known allergy to pyridine-containing substances or any of the inactive ingredients of the fampridine-SR tablet
- 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.
- A history of drug or alcohol abuse within the past year.
- Treatment with other forms of fampridine or 4-AP (e.g., compounded formulation of 4-AP) or 3,4-diaminopyridine (3,4-DAP).
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01235221
Canada, Alberta | |
Foothills Medical Center | |
Calgary, Alberta, Canada | |
Canada, British Columbia | |
University of British Columbia | |
Vancouver, British Columbia, Canada | |
Canada, New Brunswick | |
River Valley Health | |
Fredericton, New Brunswick, Canada | |
Canada, Nova Scotia | |
QEII Health Sciences Centre | |
Halifax, Nova Scotia, Canada | |
Canada, Ontario | |
Ottawa Hospital General Campus | |
Ottawa, Ontario, Canada |
Study Director: | Medical Director | Biogen |
Responsible Party: | Biogen |
ClinicalTrials.gov Identifier: | NCT01235221 |
Other Study ID Numbers: |
218MS301 |
First Posted: | November 5, 2010 Key Record Dates |
Last Update Posted: | July 4, 2014 |
Last Verified: | July 2014 |
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases |
Autoimmune Diseases Immune System Diseases 4-Aminopyridine Potassium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |