NCT01235221CompletedPhase 3
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Biogen
- Enrollment
- 38
- Locations
- 5
- Primary Endpoint
- Adverse events (AEs) and serious adverse events (SAEs) as well as Changes in vital signs and clinical laboratory assessments
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
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.
Arms & Interventions
BIIB041 (Fampridine-SR)
Experimental
Participants take 10 mg sustained-release tablets of fampridine twice daily for up to 27 months or until the product is commercially available.
Intervention: BIIB041 (Fampridine-SR) (Drug)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (5)
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