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Study of Oral Fampridine-SR in Multiple Sclerosis
This study has been completed.
Sponsored by: 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

MedlinePlus related topics: Multiple Sclerosis
Drug Information available for: 4-Aminopyridine
U.S. FDA Resources
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

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

Related Info  This link exits the ClinicalTrials.gov site

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  
Health Authority: United States: Food and Drug Administration

Keywords provided by Acorda Therapeutics:
Walking Ability

Study placed in the following topic categories:
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 January 16, 2009