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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
213

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Acorda Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2002

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2002

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2002

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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