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Study of Oral Fampridine-SR in Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by:
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT00127530
First received: August 4, 2005
Last updated: May 11, 2011
Last verified: May 2011
History of Changes
  Purpose

To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled, parallel group study.


Condition Intervention Phase
Multiple Sclerosis
 Drug: Fampridine-SR
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:

U.S. FDA Resources

Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk) [ Time Frame: Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period. ] [ Designated as safety issue: No ]
    Patients who showed a faster walking speed for at least three of the four on-drug visits during the double-blind treatment period as compared to the maximum speed for any of the five off-drug visits.


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
Placebo Comparator: Placebo- sugar pill
Placebo control
 Drug: Placebo
sugar pill, twice a day (b.i.d.)
Other Name: placebo
Experimental: Fampridine-SR
10 milligram (mg) tablet b.i.d.
 Drug: Fampridine-SR
Tablets, 10 mg, twice daily, 14 weeks
Other Name: Sustained release 4-aminopyridine, 4-AP

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 subjects with MS.

  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
Investigators
Study Director: Andrew Blight, PhD Acorda Therapeutics
  More Information

Publications:

Responsible Party: Andrew Blight/Chief Scientific Officer, Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT00127530     History of Changes
Other Study ID Numbers: MS-F203
Study First Received: August 4, 2005
Results First Received: April 12, 2011
Last Updated: May 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Acorda Therapeutics:
Walking Ability

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

ClinicalTrials.gov processed this record on May 22, 2013