Study of Oral Fampridine-SR in Multiple Sclerosis - Full Text View

Sponsor:	Acorda Therapeutics
Information provided by:	Acorda Therapeutics
ClinicalTrials.gov Identifier:	NCT00127530

Purpose

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 has been reported to possibly improve muscle strength and walking ability for some people with MS. This study will evaluate the effects and possible risks of taking Fampridine-SR in subjects with MS.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Fampridine-SR (4-aminopyridine, 4-AP)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Double-Blind, Placebo-Controlled, 21-Week, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: 4-Aminopyridine

U.S. FDA Resources

Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:

Percentage of responders on the Timed-25 foot Walk [ Time Frame: Days 14, 42, 70 and 98 of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Lower extremity manual muscle test; Ashworth Score for Spasticity [ Time Frame: Days 14, 42, 70, 98 ] [ Designated as safety issue: No ]

Enrollment:	301
Study Start Date:	May 2005
Study Completion Date:	September 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo control	Drug: Fampridine-SR (4-aminopyridine, 4-AP) Tablets, 10 mg, twice daily, 14 weeks
2: Experimental 10 mg b.i.d.	Drug: Fampridine-SR (4-aminopyridine, 4-AP) Tablets, 10 mg, twice daily, 14 weeks

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have a confirmed diagnosis of multiple sclerosis
Are able to walk with or without an assistive 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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127530

Show 34 Study Locations

Sponsors and Collaborators

Acorda Therapeutics

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Acorda Therapeutics

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Goodman AD, Brown TR, Krupp LB, Schapiro RT, Schwid SR, Cohen R, Marinucci LN, Blight AR; Fampridine MS-F203 Investigators. Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial. Lancet. 2009 Feb 28;373(9665):732-8.

Responsible Party:	Acorda Therapeutics ( Andrew Blight/Chief Scientific Officer )
Study ID Numbers:	MS-F203
Study First Received:	August 4, 2005
Last Updated:	December 29, 2008
ClinicalTrials.gov Identifier:	NCT00127530 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Acorda Therapeutics:

Walking Ability

Additional relevant MeSH terms:

Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Sclerosis
Cardiovascular Agents
Pharmacologic Actions

Membrane Transport Modulators
Multiple Sclerosis
Pathologic Processes
Therapeutic Uses
Potassium Channel Blockers
Demyelinating Autoimmune Diseases, CNS
4-Aminopyridine
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on February 08, 2010