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.
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
1 other identifier
interventional
38
1 country
5
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) 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 multiple-sclerosis
Started Dec 2010
Shorter than P25 for phase_3 multiple-sclerosis
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2010
CompletedFirst Posted
Study publicly available on registry
November 5, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJuly 4, 2014
July 1, 2014
1.5 years
November 4, 2010
July 3, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events (AEs) and serious adverse events (SAEs) as well as Changes in vital signs and clinical laboratory assessments
From Screening (Day 0) to Termination (Month 27)
Study Arms (1)
BIIB041 (Fampridine-SR)
EXPERIMENTALParticipants take 10 mg sustained-release tablets of fampridine twice daily for up to 27 months or until the product is commercially available.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
- Acorda Therapeuticscollaborator
Study Sites (5)
Foothills Medical Center
Calgary, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
River Valley Health
Fredericton, New Brunswick, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Ottawa Hospital General Campus
Ottawa, Ontario, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2010
First Posted
November 5, 2010
Study Start
December 1, 2010
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
July 4, 2014
Record last verified: 2014-07