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Thread: Acorda: Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting from Spinal Cord Injury

  1. #1

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

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

    This study is currently recruiting patients.

    Sponsored by

    Acorda

    Purpose

    Normallly, 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.

    Condition Treatment or Intervention Phase
    Muscle Spasticity

    テつ*Drug:テつ*Fampridine-SR

    Phase III



    MEDLINEplusテつ*related topics:テつ*テつ*Movementテつ*Disorders

    Study Type:テつ*Interventional
    Study Design:テつ*Treatment,テつ*Randomized,テつ*Double-Blind Method,テつ*Placebo Control,テつ*Parallel Assignment,テつ*Safety/Efficacy Study

    Official Title:テつ*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

    Eligibility

    Ages Eligible for Study:テつ* 18 Years テつ* - テつ* 70 Years,テつ* Genders Eligible for Study:テつ* Both

    Criteria


    Inclusion Criteria:
    * Incomplete traumatic Spinal Cord Injury (at least 18 months prior and stable for 6 months)
    * Moderate to severe lower-limb spasticity
    * Level of injury between C4 and T10
    * 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

    Expected Total Enrollment:テつ* 360

    Location and Contact Information

    HealthCare Partners テつ* テつ* テつ*1-866-206-2322テつ* テつ* www.acorda.comテつ*

    Alabama

    HEALTHSOUTH Metrowest Hospital,テつ*Fairfield, テつ* Alabama, テつ* 35064, テつ* United States;テつ*Recruiting

    UAB School of Medicine, 190 Spain Rehab Center,テつ*Birmingham, テつ* Alabama, テつ* 35233, テつ* United States;テつ*Recruiting

    Arizona

    Barrow Neurological Institute,テつ*Phoenix, テつ* Arizona, テつ* 85013, テつ* United States;テつ*Recruiting

    Arkansas

    Baptist Medical Center,テつ*Little Rock, テつ* Arkansas, テつ* 72205, テつ* United States;テつ*Not yet recruiting

    California

    University of California, Davis,テつ*Sacramento, テつ* California, テつ* 95817, テつ* United States;テつ*Not yet recruiting

    VA Palo Alto Health Care System,テつ*Palo Alto, テつ* California, テつ* 94304, テつ* United States;テつ*Recruiting

    Casa Colina Centers for Rehabilitatve Medicine,テつ*Pomona, テつ* California, テつ* 91769, テつ* United States;テつ*Not yet recruiting

    Santa Clara Valley Medical Center,テつ*San Jose, テつ* California, テつ* 95128, テつ* United States;テつ*Recruiting

    Colorado

    Craig Hospital,テつ*Englewood, テつ* Colorado, テつ* 80110, テつ* United States;テつ*Recruiting

    Connecticut

    Hospital for Special Care,テつ*New Britain, テつ* Connecticut, テつ* 06503, テつ* United States;テつ*Recruiting

    Delaware

    Neurology Associates, P.A.,テつ*Wilmington, テつ* Delaware, テつ* 19806, テつ* United States;テつ*Recruiting

    District of Columbia

    National Rehabilitation Hospital,テつ*Washington, テつ* District of Columbia, テつ* 20010, テつ* United States;テつ*Not yet recruiting

    Florida

    HEALTHSOUTH Sunrise Rehabilitation Hospital,テつ*Sunrise, テつ* Florida, テつ* 33351, テつ* United States;テつ*Recruiting

    Miami Center to Cure Paralysis at the Univ. of Miami School of Medicine,テつ*Miami, テつ* Florida, テつ* 33136, テつ* United States;テつ*Not yet recruiting

    Tampa General Hospital,テつ*Tampa, テつ* Florida, テつ* 33606, テつ* United States;テつ*Not yet recruiting

    Georgia

    Shepherd Spinal Center,テつ*Atlanta, テつ* Georgia, テつ* 30309, テつ* United States;テつ*Recruiting

    Illinois

    Advocate Christ Medical Center-Dept. of Physical Medicine & Rehabilitation-EMG,テつ*Oak Lawn, テつ* Illinois, テつ* 60453, テつ* United States;テつ*Not yet recruiting

    Springfield Clinic-Neuroscience Institute,テつ*Springfield, テつ* Illinois, テつ* 62702, テつ* United States;テつ*Recruiting

    Schwab Rehabilitation Hospital,テつ*Chicago, テつ* Illinois, テつ* 60608, テつ* United States;テつ*Not yet recruiting

    Rehabilitation Institute of Chicago,テつ*Chicago, テつ* Illinois, テつ* 60611, テつ* United States;テつ*Recruiting

    Hines VA Hospital,テつ*Hines, テつ* Illinois, テつ* 60141, テつ* United States;テつ*Not yet recruiting

    Maryland

    Department of PM&R John's Hopkins School of Medicine,テつ*Baltimore, テつ* Maryland, テつ* 21239, テつ* United States;テつ*Not yet recruiting

    Massachusetts

    HEALTHSOUTH Braintree Rehabilitation Hospital,テつ*Braintree, テつ* Massachusetts, テつ* 02185, テつ* United States;テつ*Recruiting

    HEALTHSOUTH New England Rehabilitation Hospital,テつ*Woburn, テつ* Massachusetts, テつ* 01801, テつ* United States;テつ*Recruiting

    Boston University Medical Center,テつ*Boston, テつ* Massachusetts, テつ* 02118, テつ* United States;テつ*Not yet recruiting

    Michigan

    Mary Free Bed Hospital & Rehabilitation Center,テつ*Grand Rapids, テつ* Michigan, テつ* 49503, テつ* United States;テつ*Recruiting

    University of Michigan,テつ*Ann Arbor, テつ* Michigan, テつ* 48109, テつ* United States;テつ*Recruiting

    Rehabilitation Institute of Michigan,テつ*Detroit, テつ* Michigan, テつ* 48201, テつ* United States;テつ*Not yet recruiting

    Minnesota

    Minneapolis VA Hospital,テつ*Minneapolis, テつ* Minnesota, テつ* 55417, テつ* United States;テつ*Recruiting

    Mayo Clinic,テつ*Rochester, テつ* Minnesota, テつ* 55905, テつ* United States;テつ*Not yet recruiting

    Missouri

    University of Missouri,テつ*Columbia, テつ* Missouri, テつ* 65212, テつ* United States;テつ*Recruiting

    Washington University School of Medicine, Div. of Rehab/Neurology,テつ*St. Louis, テつ* Missouri, テつ* 63110, テつ* United States;テつ*Not yet recruiting

    New Jersey

    VA-New Jersey Health Care System,テつ*East Orange, テつ* New Jersey, テつ* 07018, テつ* United States;テつ*Not yet recruiting

    Cooper Health System,テつ*Camden, テつ* New Jersey, テつ* 08103, テつ* United States;テつ*Not yet recruiting

    Kessler Institute of Rehabilitation,テつ*West Orange, テつ* New Jersey, テつ* 07052, テつ* United States;テつ*Not yet recruiting

    New York

    SUNY Upstate Clinical Trials Office,テつ*Syracuse, テつ* New York, テつ* 13045, テつ* United States;テつ*Not yet recruiting

    The Burke Rehabilitation Hospital,テつ*White Plains, テつ* New York, テつ* 10605, テつ* United States;テつ*Recruiting

    University of Rochester/Strong Memorial Hospital,テつ*Rochester, テつ* New York, テつ* 14642, テつ* United States;テつ*Not yet recruiting

    North Carolina

    Wake Forest University,テつ*Winston Salem, テつ* North Carolina, テつ* 27157, テつ* United States;テつ*Recruiting

    UNC Chapel Hill,テつ*Chapel Hill, テつ* North Carolina, テつ* 27599, テつ* United States;テつ*Not yet recruiting

    East Carolina University,テつ*Greenville, テつ* North Carolina, テつ* 27858, テつ* United States;テつ*Recruiting

    Coastal AHEC,テつ*Wilmington, テつ* North Carolina, テつ* 28402, テつ* United States;テつ*Recruiting

    Charlotte Institute of Rehabilitation,テつ*Charlotte, テつ* North Carolina, テつ* 28203, テつ* United States;テつ*Not yet recruiting

    North Dakota

    Clinical Research Services,テつ*Bismarck, テつ* North Dakota, テつ* 58501, テつ* United States;テつ*Recruiting

    Ohio

    Cleveland VAMC,テつ*Cleveland, テつ* Ohio, テつ* 44106, テつ* United States;テつ*Not yet recruiting

    Drake Center,テつ*Cincinnati, テつ* Ohio, テつ* 45216, テつ* United States;テつ*Not yet recruiting

    Miami Valley Hospital- Rehabilitation Institute of Medicine,テつ*Dayton, テつ* Ohio, テつ* 45409, テつ* United States;テつ*Not yet recruiting

    Ohio State University,テつ*Columbus, テつ* Ohio, テつ* 43210, テつ* United States;テつ*Recruiting

    Pennsylvania

    Northeastern Rehabilitation Associates,テつ*Scranton, テつ* Pennsylvania, テつ* 18501, テつ* United States;テつ*Not yet recruiting

    Bryn Mawr Rehabilitation Hospital,テつ*Malvern, テつ* Pennsylvania, テつ* 19355, テつ* United States;テつ*Not yet recruiting

    HEALTHSOUTH Harmarville Rehabilitation Hospital,テつ*Pittsburgh, テつ* Pennsylvania, テつ* 15238, テつ* United States;テつ*Recruiting

    Thomas Jefferson University Hospital,テつ*Philadelphia, テつ* Pennsylvania, テつ* 19107, テつ* United States;テつ*Recruiting

    University of Pittsburgh,テつ*Pittsburgh, テつ* Pennsylvania, テつ* 15213, テつ* United States;テつ*Not yet recruiting

    Texas

    VA North Texas Health Care System,テつ*Dallas, テつ* Texas, テつ* 75216, テつ* United States;テつ*Not yet recruiting

    Southwestern Medical Center at Dallas,テつ*Dallas, テつ* Texas, テつ* 75390, テつ* United States;テつ*Recruiting

    Utah

    Rehabilitation Services University of Utah Hospitals and Clinics,テつ*Salt Lake City, テつ* Utah, テつ* 84132, テつ* United States;テつ*Recruiting

    Virginia

    Richmond VA Medical Center (Hunter Holmes McGuire),テつ*Richmond, テつ* Virginia, テつ* 23249, テつ* United States;テつ*Recruiting

    Hamptom VA Hospital,テつ*Hampton, テつ* Virginia, テつ* 23667, テつ* United States;テつ*Recruiting

    Medical College of Virginia/VCU,テつ*Richmond, テつ* Virginia, テつ* 23298, テつ* United States;テつ*Recruiting

    INOVA Institute of Research and Education,テつ*Falls Church, テつ* Virginia, テつ* 22042, テつ* United States;テつ*Not yet recruiting

    Washington

    University of Washington Medical Center, Dept. of Rehabilitation,テつ*Seattle, テつ* Washington, テつ* 98195, テつ* United States;テつ*Recruiting

    West Virginia

    CAMC Health Education & Research Institute,テつ*Charleston, テつ* West Virginia, テつ* 25304, テつ* United States;テつ*Recruiting

    Wisconsin

    Wood VA Medical Center,テつ*Milwaukee, テつ* Wisconsin, テつ* 53295, テつ* United States;テつ*Recruiting

    Canada,テつ*Alberta

    Glenrose Rehabilitation Hospital,テつ*Edmonton, テつ* Alberta, テつ* T5G 0B7, テつ* Canada;テつ*Not yet recruiting

    Foothills Provincial General Hospital,テつ*Calgary, テつ* Alberta, テつ* T2N 2T9, テつ* Canada;テつ*Recruiting

    Canada,テつ*British Columbia

    G.F. Strong Rehabilitation Centre,テつ*Vancouver, テつ* British Columbia, テつ* V5Z 2G9, テつ* Canada;テつ*Not yet recruiting

    Canada,テつ*Manitoba

    Health Sciences Centre,テつ*Winnipeg, テつ* Manitoba, テつ* R3A 1M4, テつ* Canada;テつ*Recruiting

    Canada,テつ*New Brunswick

    Stan Cassidy Centre for Rehabilitation,テつ*Fredericton, テつ* New Brunswick, テつ* E3B 4R3, テつ* Canada;テつ*Recruiting

    Canada,テつ*Nova Scotia

    QEII HSC-Nova Scotia Rehabilitation Centre,テつ*Halifax, テつ* Nova Scotia, テつ* B3M 4K4, テつ* Canada;テつ*Recruiting

    Canada,テつ*Ontario

    St. Mary's of the Lake Hospital,テつ*Kingston, テつ* Ontario, テつ* K7L 5A2, テつ* Canada;テつ*Not yet recruiting

    Toronto Rehabilitation Institute, Lyndhurst Centre,テつ*Toronto, テつ* Ontario, テつ* M5G 3V9, テつ* Canada;テつ*Not yet recruiting

    Chedoke-McMaster Hospital,テつ*Hamilton, テつ* Ontario, テつ* L8N 3Z5, テつ* Canada;テつ*Not yet recruiting

    The Rehabilitation Centre,テつ*Ottawa, テつ* Ontario, テつ* K1H 8M2, テつ* Canada;テつ*Not yet recruiting

    Parkwood Hospital Site, St. Joseph's Health Care,テつ*London, テつ* Ontario, テつ* N6C 5J1, テつ* Canada;テつ*Recruiting

    More Information

    Study ID Numbersテつ* SCI-F301/302

    Date study startedテつ*June 2002;テつ* Study Completion Dateテつ* February 2003
    Record last reviewedテつ* July 2002

    NLM Identifierテつ* NCT00041717
    ClinicalTrials.gov processed this record on 2002-08-23

  2. #2

    criteria for exclusion

    "* Existing or history of frequent Urinary Tract Infections"

    This could eliminate the majority of us.


  3. #3
    rtr, I don't think that should be the case. I think that they are referring to people who have an active urinary tract infection that requires antibiotics. This is to avoid having antibiotics interfere with Fampridine. Wise.

  4. #4
    I passed the first round of questions to meet their requirements. I hope to hear more in 6-8 weeks.

  5. #5
    I got the call to come down to the hospital to get signed up and go through the test for trial. What happen in the first go around? What do they check for? Do you start the drug then or does it take a while to get it a going? I'm going down next Thursday!

  6. #6
    Originally posted by TIGGER74:

    I got the call to come down to the hospital to get signed up and go through the test for trial. What happen in the first go around? What do they check for? Do you start the drug then or does it take a while to get it a going? I'm going down next Thursday!
    You are further along than me. I just answered a few questions from Acorda. She said that the local trial center will contact me in 6 weeks or so. I haven't heard from the local center yet. Good luck! Let me know what happens.

  7. #7
    Senior Member Jeremy's Avatar
    Join Date
    Jul 2001
    Location
    Canada
    Posts
    588
    Same here about 6 weeks from first call, just waiting now.

    "If the wind could blow my troubles away. I'd stand in front of a hurricane."

  8. #8
    Senior Member TD's Avatar
    Join Date
    Aug 2001
    Location
    Phoenix, AZ, USA
    Posts
    649

    UTI criteria answer

    Originally posted by rtr:

    "* Existing or history of frequent Urinary Tract Infections"

    This could eliminate the majority of us.

    The criteria is no more than 3 UTIs in the past 12 months. The Phoenix trial is starting now and they need more participants!!

    "And so it begins."

  9. #9
    Originally posted by TD:

    Originally posted by rtr:
    "* Existing or history of frequent Urinary Tract Infections"

    This could eliminate the majority of us.

    The criteria is no more than 3 UTIs in the past 12 months. The Phoenix trial is starting now and they need more participants!!

    "And so it begins."
    That's a bunch of crap... What is the reason for this? When you in and out cath it's hard not to have utis... i don't every get fever or cold chills but i do get a lot of white stuff coming out...

    [This message was edited by TIGGER74 on Sep 13, 2002 at 10:29 PM.]

  10. #10
    Originally posted by Wise Young:

    rtr, I don't think that should be the case. I think that they are referring to people who have an active urinary tract infection that requires antibiotics. This is to avoid having antibiotics interfere with Fampridine. Wise.
    Don't skip your appointment without calling your doctor to verify the uti requirement.

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