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

Tracking Information
First Received Date ^ICMJE	January 29, 2003
Last Updated Date	December 29, 2008
Start Date ^ICMJE	February 2003
Primary Completion Date	December 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 29, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00053417 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of Oral Fampridine-SR on Walking Ability in Multiple Sclerosis
Official Title ^ICMJE	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 ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Multiple Sclerosis
Intervention ^ICMJE	Drug: Fampridine-SR (4-aminopyridine, 4-AP)
Study Arms / Comparison Groups	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.
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	206
Completion Date	December 2003
Primary Completion Date	December 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT ID ^ICMJE	NCT00053417
Responsible Party	Andrew Blight/Chief Scientific Officer, Acorda Therapeutics
Study ID Numbers ^ICMJE	MS-F202
Study Sponsor ^ICMJE	Acorda Therapeutics
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Acorda Therapeutics
Verification Date	December 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP