Study of Fampridine-SR Tablets in Multiple Sclerosis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00483652
Recruitment Status : Completed
First Posted : June 7, 2007
Results First Posted : April 14, 2011
Last Update Posted : February 4, 2016
Information provided by (Responsible Party):
Acorda Therapeutics

Brief Summary:
The purpose of the study is to show that individuals treated with Fampridine-SR tablets are significantly more likely to have consistent improvements in their walking than those treated with placebo tablets.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Fampridine-SR Drug: Placebo Phase 3

Detailed Description:
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 MS patients

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR (10 mg b.i.d. [Bis in Die, Twice Daily]) in Patients With Multiple Sclerosis
Study Start Date : May 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo control
Drug: Placebo
placebo (sugar pill)
Active Comparator: Fampridine-SR
10 mg b.i.d.
Drug: Fampridine-SR
Tablets, 10 mg, twice daily, 9 weeks
Other Name: 4-aminopyridine

Primary Outcome Measures :
  1. Responders Based Upon the Timed 25-Foot Walk [T25FW] [ Time Frame: Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77 ]
    A responder is a patient who showed faster walking speed for at least 3 visits out of a possible 4 during the double-blind period than the maximum value achieved in the 5 non-double-blind no-treatment visits (4 before the double-blind period and one after)

Secondary Outcome Measures :
  1. Change in Lower Extremity Manual Muscle Test [LEMMT] [ Time Frame: Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77 ]
    Evaluator rated strength in hip flexors, knee flexors, knee extensors, and ankle dorsiflexors on the following scale: best value = 5.0 (normal muscle strength), worst value = 0.0 (absence of any voluntary contraction). A positive shift in LEMMT score shows improvement in strength. Change in LEMMT scores for the secondary efficacy measure was found by averaging the LEMMT scores on days 14, 28, 42, and 56 (double-blind treatment period) and subtracting the baseline LEMMT score.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient with clinically defined multiple sclerosis
  • All patients must be able to complete two trials of a timed 25 foot walk

Exclusion Criteria:

  • Female patients who are either pregnant or breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00483652

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Sponsors and Collaborators
Acorda Therapeutics
Study Director: Andrew Blight, PhD Acorda Therapeutics

Additional Information:
Publications of Results:
Responsible Party: Acorda Therapeutics Identifier: NCT00483652     History of Changes
Other Study ID Numbers: MS-F204
First Posted: June 7, 2007    Key Record Dates
Results First Posted: April 14, 2011
Last Update Posted: February 4, 2016
Last Verified: January 2016

Keywords provided by Acorda Therapeutics:
multiple sclerosis
leg strength

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action