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

[Wise Young]

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

Â*Drug:Â*Fampridine-SR

Phase III



MEDLINEplusÂ*related topics:Â*Â*MovementÂ*Disorders

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

Official Title:Â*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:Â* 18 Years Â* - Â* 70 Years,Â* Genders Eligible for Study:Â* 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:Â* 360

Location and Contact Information

HealthCare Partners Â* Â* Â*1-866-206-2322Â* Â* www.acorda.comÂ*

Alabama

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

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

Arizona

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

Arkansas

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

California

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

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

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

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

Colorado

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

Connecticut

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

Delaware

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

District of Columbia

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

Florida

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

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

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

Georgia

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

Illinois

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

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

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

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

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

Maryland

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

Massachusetts

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

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

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

Michigan

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

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

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

Minnesota

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

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

Missouri

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

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

New Jersey

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

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

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

New York

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

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

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

North Carolina

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

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

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

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

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

North Dakota

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

Ohio

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

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

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

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

Pennsylvania

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

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

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

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

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

Texas

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

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

Utah

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

Virginia

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

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

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

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

Washington

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

West Virginia

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

Wisconsin

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

Canada,Â*Alberta

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

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

Canada,Â*British Columbia

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

Canada,Â*Manitoba

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

Canada,Â*New Brunswick

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

Canada,Â*Nova Scotia

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

Canada,Â*Ontario

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

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

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

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

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

More Information

Study ID NumbersÂ* SCI-F301/302

Date study startedÂ*June 2002;Â* Study Completion DateÂ* February 2003
Record last reviewedÂ* July 2002

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

[rtr]

"* Existing or history of frequent Urinary Tract Infections"

This could eliminate the majority of us.

[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.

[rtr]

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

[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!

[rtr]

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.

[Jeremy]

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."

[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."

[tigger74]

Originally posted by TD:

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.]

[rtr]

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.