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

August 3, 2011 updated by: Acorda Therapeutics

Double-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Phase 2

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 Centre
    • Ontario
      • Toronto, Ontario, Canada, M5B 1WB
        • St. Michael's Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute at St. Joseph Hospital and Medical Center
    • California
      • Los Angeles, California, United States, 90033
        • USC MS Comprehensive Care Center
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University MS Center
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Shepherd Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Maryland
      • Baltimore, Maryland, United States, 21210
        • University of Maryland at Baltimore
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Fairview MS Center
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Gimbel MS Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico
    • New York
      • Brooklyn, New York, United States, 11219
        • Maimonides MS Care Center
      • New York, New York, United States, 10029
        • Mt. Sinai School of Medicine - MS Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical School
      • Stony Brook, New York, United States, 11794
        • SUNY Stony Brook
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Carolinas Medical Center MS Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health Sciences University; MS Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas-Houston
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington School of Medicine
      • Seattle, Washington, United States, 98122
        • Swedish Medical MS Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics

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:

  • 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)

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: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline (placebo run-in period); 12-week stable dose period

Collaborators and Investigators

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

Sponsor

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.

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

February 1, 2003

Primary Completion (Actual)

December 1, 2003

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

January 29, 2003

First Submitted That Met QC Criteria

January 29, 2003

First Posted (Estimate)

January 30, 2003

Study Record Updates

Last Update Posted (Estimate)

August 4, 2011

Last Update Submitted That Met QC Criteria

August 3, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-F202

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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