Full Text View
Tabular View
No Study Results Posted
Related Studies
Safety and Efficacy Study of Oral Fampridine-SR on Walking Ability in Multiple Sclerosis
This study has been completed.
Study NCT00053417   Information provided by Acorda Therapeutics
First Received: January 29, 2003   Last Updated: December 29, 2008   History of Changes

January 29, 2003
December 29, 2008
February 2003
December 2003   (final data collection date for primary outcome measure)
Percent change from baseline in average walking speed measured using the Timed 25-Foot Walk Test from the Multiple Sclerosis Functional Composite (MSFC) [ Time Frame: Visits 5, 6, 7, 8 and 9 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00053417 on ClinicalTrials.gov Archive Site
 
 
 
Safety and Efficacy Study of Oral Fampridine-SR on Walking Ability in Multiple Sclerosis
Double-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis

Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the Central Nervous System (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will evaluate the effects of Fampridine-SR on the walking ability of subjects with MS, as well as to examine the effects on muscle strength and spasticity. The study will also examine the possible risks of taking Fampridine-SR.

 
Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Multiple Sclerosis
Drug: Fampridine-SR (4-aminopyridine, 4-AP)
  • Placebo Comparator: Placebo control
  • Experimental: 10 mg fampridine b.i.d.
  • Experimental: 15 mg fampridine b.i.d.
  • Experimental: 20 mg fampridine b.i.d.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
206
December 2003
December 2003   (final data collection date for primary outcome measure)

INCLUSION CRITERIA:

  • Have a confirmed diagnosis of Multiple Sclerosis
  • Are able to walk with or without an assisted device

EXCLUSION CRITERIA:

  • Pregnancy, breastfeeding or females of childbearing potential not using adequate birth control
  • Participating in other investigational drug trials
  • A medical history or clinical findings that preclude entry into the study
  • A medication history that precludes entry into the study
  • Previously treated with 4-aminopyridine (4-AP)
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00053417
Andrew Blight/Chief Scientific Officer, Acorda Therapeutics
MS-F202
Acorda Therapeutics
 
 
Acorda Therapeutics
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP