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Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT00053417
Recruitment Status : Completed
First Posted : January 30, 2003
Results First Posted : August 4, 2011
Last Update Posted : August 4, 2011
Sponsor:
Information provided by:
Acorda Therapeutics

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 (Sustained Release, 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 or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Placebo Drug: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP) Drug: 15 mg fampridine-SR (4-aminopyridine, 4-AP) Drug: 20 mg fampridine-SR (4-aminopyridine, 4-AP) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : February 2003
Actual Primary Completion Date : December 2003
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1
Placebo control, twice a day (b.i.d.)
Drug: Placebo
Placebo for 15 weeks
Experimental: 2
10 milligram (mg) fampridine b.i.d.
Drug: 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP)

2 week up titration (10 mg)

12 weeks stable dose (10 mg)

1 week down titration (10 mg)

Experimental: 3
15 mg fampridine b.i.d.
Drug: 15 mg fampridine-SR (4-aminopyridine, 4-AP)

10 mg twice daily for 1 week

15 mg twice daily for 14 weeks

2 week up titration (10 mg x 1 week, 15 mg x 1 week)

12 weeks stable dose (15 mg)

1 week down titration (10 mg)

Experimental: 4
20 mg fampridine b.i.d.
Drug: 20 mg fampridine-SR (4-aminopyridine, 4-AP)

2 week up titration (10 mg x 1 week, 15 mg x 1 week)

12 weeks stable dose (20 mg)

1 week down titration (15 mg x 3 days, 10 mg x 4 days)




Primary Outcome Measures :
  1. Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test [ Time Frame: Baseline (placebo run-in period); 12-week stable dose period ]
    The primary efficacy variable was the percent change from baseline in average walking speed measured using the Timed 25-Foot Walk Test during the 12-week stable dose period (the average of Study Days 56, 84, and 112), relative to the mean at baseline (placebo run-in period, the average of Study Days 7 and 14).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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)

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 ClinicalTrials.gov identifier (NCT number): NCT00053417


  Show 25 Study Locations
Sponsors and Collaborators
Acorda Therapeutics

Additional Information:
Responsible Party: Andrew Blight/Chief Scientific Officer, Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT00053417     History of Changes
Other Study ID Numbers: MS-F202
First Posted: January 30, 2003    Key Record Dates
Results First Posted: August 4, 2011
Last Update Posted: August 4, 2011
Last Verified: August 2011

Keywords provided by Acorda Therapeutics:
Walking Ability
Muscle strength
Spasticity

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