Status:
COMPLETED
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.
Lead Sponsor:
Biogen
Collaborating Sponsors:
Acorda Therapeutics
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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) w...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01235221
Start Date
December 1 2010
End Date
June 1 2012
Last Update
July 4 2014
Active Locations (5)
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1
Foothills Medical Center
Calgary, Alberta, Canada
2
University of British Columbia
Vancouver, British Columbia, Canada
3
River Valley Health
Fredericton, New Brunswick, Canada
4
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada