Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury

January 6, 2020 updated by: Acorda Therapeutics

Double-Blind, Placebo-Controlled, 12-Week Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Moderate to Severe Spasticity Resulting From Chronic, Incomplete Spinal Cord Injury

Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with spinal cord injury, some fibers may be destroyed at the site of injury, while others remain connected but do not work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal cord injury may have spasticity which is muscle spasms or muscle stiffness that makes movement difficult. Fampridine-SR is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as bladder control, bowel function and sexual function. The study will also examine the possible risks of taking Fampridine-SR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

213

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 Provincial General Hospital
      • Edmonton, Alberta, Canada, T5G 0B7
        • Glenrose Rehabilitation Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 2G9
        • G.F. Strong Rehabilitation Centre
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 4R3
        • Stan Cassidy Centre for Rehabilitation
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3M 4K4
        • QEII HSC-Nova Scotia Rehabilitation Centre
    • Ontario
      • London, Ontario, Canada, N6C 5J1
        • Parkwood Hospital Site, St. Joseph's Health Care
      • Ottawa, Ontario, Canada, K1H 8M2
        • The Rehabilitation Centre
      • Toronto, Ontario, Canada, M5G 3V9
        • Toronto Rehabilitation Institute, Lyndhurst Centre
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Lakeshore Rehabilitation Hospital
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Baptist Medical Center
    • California
      • Palo Alto, California, United States, 94304
        • VA Palo Alto Health Care System
      • Pasadena, California, United States, 91005
        • Neuro-Therapeutics, Inc
    • Delaware
      • Wilmington, Delaware, United States, 19806
        • Neurology Associates, P.A.
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • National Rehabilitation Hospital
    • Florida
      • Miami, Florida, United States, 33136
        • Miami Center to Cure Paralysis at the Univ. of Miami School of Medicine
      • Sunrise, Florida, United States, 33351
        • Rehabilitation Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Shepherd Spinal Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Rehabilitation Institute of Chicago
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Christ Medical Center-Dept. of Physical Medicine & Rehabilitation-EMG
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic-Neuroscience Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Spaulding Rehabilitation Hospital
      • Braintree, Massachusetts, United States, 02185
        • HEALTHSOUTH Braintree Rehabilitation Hospital
      • Woburn, Massachusetts, United States, 01801
        • HEALTHSOUTH New England Rehabilitation Hospital
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Mary Free Bed Hospital & Rehabilitation Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine, Div. of Rehab/Neurology
    • Montana
      • Missoula, Montana, United States, 59802
        • Montana Neuroscience
    • New Jersey
      • West Orange, New Jersey, United States, 07052
        • Kessler Institute of Rehabilitation
    • New York
      • White Plains, New York, United States, 10605
        • The Burke Rehabilitation Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Chapel Hill
      • Greenville, North Carolina, United States, 27858
        • East Carolina University
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Clinical Research Services
    • Ohio
      • Cincinnati, Ohio, United States, 45216
        • Drake Center
      • Cleveland, Ohio, United States, 44106
        • Cleveland VAMC
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Good Shepherd Rehabilitation
      • Malvern, Pennsylvania, United States, 19355
        • Bryn Mawr Rehabilitation Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
      • Pittsburgh, Pennsylvania, United States, 15238
        • HEALTHSOUTH Harmarville Rehabilitation Hospital
      • Scranton, Pennsylvania, United States, 18501
        • Northeastern Rehabilitation Associates
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Rehabilitation Services University of Utah Hospitals and Clinics
    • Virginia
      • Hampton, Virginia, United States, 23667
        • Hampton VA Hospital
      • Richmond, Virginia, United States, 23249
        • Richmond VA Medical Center (Hunter Holmes McGuire)
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • CAMC Health Education & Research Institute

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:

  • Incomplete traumatic Spinal Cord Injury (at least 18 months prior and stable for 6 months)
  • Moderate to severe lower-limb spasticity
  • Able to give informed consent and willing to comply with protocol

Exclusion Criteria:

  • Pregnancy
  • History of seizures
  • Existing or history of frequent Urinary Tract Infections
  • History of drug or alcohol abuse
  • Allergy to pyridine-containing substances
  • Received a botox injection 4 months prior to study
  • Received an investigational drug within 30 days
  • Previously treated with 4-aminopyridine (4-AP)
  • Not on stable medication dosing in 3 weeks prior to study
  • Abnormal ECG or laboratory value at screening

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Placebo
Active Comparator: fampridine-SR 50mg/day
Drug: Fampridine-SR
25mg bid (twice daily)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity
Time Frame: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
The Ashworth Score is the average rating (based on a scale of 1 to 5) of four lower extremity muscle groups; left and right knee flexors and extensors (hamstrings and quadriceps muscles). A higher Ashworth Score indicates a greater degree of abnormal muscle tone (spasticity) and a negative change in score indicates improvement.
Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment
Time Frame: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
This questionnaire asked the patient to evaluate the effects of investigational drug on his/her quality of life during the preceding week using a 7-point scale (from 1=terrible to 7=delighted). A positive change score in SGI indicates improved outcome.
Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98

Collaborators and Investigators

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

Sponsor

Acorda Therapeutics

Investigators

  • Study Director: Andrew Blight, 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

July 1, 2002

Primary Completion (Actual)

February 1, 2004

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

July 12, 2002

First Submitted That Met QC Criteria

July 15, 2002

First Posted (Estimate)

July 16, 2002

Study Record Updates

Last Update Posted (Actual)

January 14, 2020

Last Update Submitted That Met QC Criteria

January 6, 2020

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCI-F301

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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