Study of Fampridine-SR Tablets in Multiple Sclerosis Patients

January 4, 2016 updated by: Acorda Therapeutics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Medical Center
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • University of British Columbia, Vancouver Coastal Health Research Institute
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 0C7
        • River Valley Health c/o Stan Cassidy Centre for Rehabilitation
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 4K4
        • QEII Health Sciences Centre, Nova Scotia Rehabilitation Centre Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • Hope Research Institute
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurology Clinic, St. Joseph's Hospital and Medical Center
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Neurological Associates
    • California
      • Berkeley, California, United States, 94705
        • Alta Bates Summit Medical Center - Research and Education Institute
      • Los Angeles, California, United States, 90033
        • USC, Keck School of Medicine Health Care Consultation Center
      • Sacramento, California, United States, 95817
        • UC Davis
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University MS Center
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Shepherd Center
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Consultants in Neurology, Ltd.
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University MS Center
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Associates in Neurology, PSC
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Maryland Center for MS
    • Massachusetts
      • Lexington, Massachusetts, United States, 02421
        • Lahey Clinic
    • Minnesota
      • Golden Valley, Minnesota, United States, 55422
        • The Schapiro Center for MS
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Montana
      • Great Falls, Montana, United States, 59405
        • Advanced Neurology Specialists
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • UMDNJ
      • Teaneck, New Jersey, United States, 07666
        • Gimbel MS Center at Holy Name Hospital
    • New York
      • Buffalo, New York, United States, 14203
        • Jacobs Neurological Institute Buffalo General Hospital
      • New York, New York, United States, 10029
        • Corinne Goldsmith Dickinson Center for MS
      • New York, New York, United States, 10032
        • Columbia University Multiple Sclerosis Clinical Care Center
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Stony Brook, New York, United States, 11794
        • SUNY Stony Brook
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • CMC - Neuroscience & Spine Institute, Division of Neurology
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University, Dept of Neurology, M.S. Research
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • The Center for Neurological Services
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43221
        • Ohio State University MS Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University, MS Center of Oregon, UHS-42
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Physicians
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Neurological Research Center, Inc.
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care
    • Washington
      • Kirkland, Washington, United States, 98034
        • MS Center at Evergreen
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • CAMC Health Education & Research Institute
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Center for Neurological Disorders of Aurora, St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 4-aminopyridine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acorda Therapeutics

Investigators

  • Study Director: Andrew Blight, PhD, Acorda Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

June 6, 2007

First Submitted That Met QC Criteria

June 6, 2007

First Posted (Estimate)

June 7, 2007

Study Record Updates

Last Update Posted (Estimate)

February 4, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-F204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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