A Phase 3 interventional study of BIIB041 (Fampridine-SR) in Multiple Sclerosis, sponsored by Biogen. Completed at 5 sites in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-07-04.
Sponsored by Biogen · Phase 3, Interventional, and Treatment
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).
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 38 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.
Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria :
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Participants take 10 mg sustained-release tablets of fampridine twice daily for up to 27 months or until the product is commercially available.
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.
Also known as: Dalfampridine, Fampridine-ER, Ampyra, Fampyra, Fampridine-PR
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)
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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