Safety and Efficacy Study of Oral Fampridine-SR on Walking Ability in Multiple Sclerosis - Tabular View

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Safety and Efficacy Study of Oral Fampridine-SR on Walking Ability in Multiple Sclerosis

This study has been completed.

Study NCT00053417. Last updated on June 23, 2005. Information provided by Acorda Therapeutics

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Safety and Efficacy Study of Oral Fampridine-SR on Walking Ability in Multiple Sclerosis
Official Title ^†	Double-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis
Brief Summary	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.
Detailed Description
Study Phase	Phase II
Study Type ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Multiple Sclerosis
Intervention ^†	Drug: Fampridine-SR (4-aminopyridine, 4-AP)
MEDLINE PMIDs
Links	Related Info

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	180
Start Date ^†	February 2003
Completion Date	December 2003
Eligibility Criteria ^†	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)
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States, Canada

Administrative Information Fields
NCT ID ^†	NCT00053417
Organization ID	MS-F202
Secondary IDs ^††
Study Sponsor ^†	Acorda Therapeutics
Collaborators ^††
Investigators ^†
Information Provided By	Acorda Therapeutics
Verification Date	January 2004
First Received Date ^†	January 29, 2003
Last Updated Date	June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.