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

This study has been completed.

Sponsored by: Acorda Therapeutics
Information provided by: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT00053417
  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 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.


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

MedlinePlus related topics:   Multiple Sclerosis  

ChemIDplus related topics:   4-Aminopyridine  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Acorda Therapeutics:

Estimated Enrollment:   180
Study Start Date:   February 2003
Estimated Study Completion Date:   December 2003

  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 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)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053417

 Show 25 Study Locations

Sponsors and Collaborators
Acorda Therapeutics
  More Information

Related Info  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   MS-F202
First Received:   January 29, 2003
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00053417
Health Authority:   United States: Food and Drug Administration

Keywords provided by Acorda Therapeutics:
Walking Ability  
Muscle strength  
Spasticity  

Study placed in the following topic categories:
Muscle Spasticity
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS
4-Aminopyridine
Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Membrane Transport Modulators
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Therapeutic Uses
Nervous System Diseases
Potassium Channel Blockers
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 03, 2008




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