NCT01235221

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-11-05
• Last updated: 2014-07-04

Locations

5 sites across 1 country: Canada