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

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

Sponsoren

Hauptsponsor: Acorda Therapeutics

Quelle Acorda Therapeutics
Kurze Zusammenfassung

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.

Gesamtstatus Completed
Anfangsdatum July 2002
Fertigstellungstermin May 2004
Primäres Abschlussdatum February 2004
Phase Phase 3
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity 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 Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
Einschreibung 213
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Fampridine-SR

Beschreibung: 25mg bid (twice daily)

Armgruppenetikett: fampridine-SR 50mg/day

Interventionsart: Other

Interventionsname: Placebo

Beschreibung: Placebo

Armgruppenetikett: Placebo

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 70 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Andrew Blight Study Director Acorda Therapeutics
Ort
Einrichtung:
Lakeshore Rehabilitation Hospital | Birmingham, Alabama, 35209, United States
Barrow Neurological Institute | Phoenix, Arizona, 85013, United States
Baptist Medical Center | Little Rock, Arkansas, 72205, United States
VA Palo Alto Health Care System | Palo Alto, California, 94304, United States
Neuro-Therapeutics, Inc | Pasadena, California, 91005, United States
Neurology Associates, P.A. | Wilmington, Delaware, 19806, United States
National Rehabilitation Hospital | Washington, District of Columbia, 20010, United States
Miami Center to Cure Paralysis at the Univ. of Miami School of Medicine | Miami, Florida, 33136, United States
Rehabilitation Hospital | Sunrise, Florida, 33351, United States
Shepherd Spinal Center | Atlanta, Georgia, 30309, United States
Rehabilitation Institute of Chicago | Chicago, Illinois, 60611, United States
Advocate Christ Medical Center-Dept. of Physical Medicine & Rehabilitation-EMG | Oak Lawn, Illinois, 60453, United States
Springfield Clinic-Neuroscience Institute | Springfield, Illinois, 62702, United States
Spaulding Rehabilitation Hospital | Boston, Massachusetts, 02114, United States
HEALTHSOUTH Braintree Rehabilitation Hospital | Braintree, Massachusetts, 02185, United States
HEALTHSOUTH New England Rehabilitation Hospital | Woburn, Massachusetts, 01801, United States
Mary Free Bed Hospital & Rehabilitation Center | Grand Rapids, Michigan, 49503, United States
Mayo Clinic | Rochester, Minnesota, 55905, United States
Washington University School of Medicine, Div. of Rehab/Neurology | Saint Louis, Missouri, 63110, United States
Montana Neuroscience | Missoula, Montana, 59802, United States
Kessler Institute of Rehabilitation | West Orange, New Jersey, 07052, United States
The Burke Rehabilitation Hospital | White Plains, New York, 10605, United States
UNC Chapel Hill | Chapel Hill, North Carolina, 27599, United States
East Carolina University | Greenville, North Carolina, 27858, United States
Wake Forest University | Winston-Salem, North Carolina, 27157, United States
Clinical Research Services | Bismarck, North Dakota, 58501, United States
Drake Center | Cincinnati, Ohio, 45216, United States
Cleveland VAMC | Cleveland, Ohio, 44106, United States
Good Shepherd Rehabilitation | Allentown, Pennsylvania, 18103, United States
Bryn Mawr Rehabilitation Hospital | Malvern, Pennsylvania, 19355, United States
University of Pittsburgh | Pittsburgh, Pennsylvania, 15213, United States
HEALTHSOUTH Harmarville Rehabilitation Hospital | Pittsburgh, Pennsylvania, 15238, United States
Northeastern Rehabilitation Associates | Scranton, Pennsylvania, 18501, United States
Rehabilitation Services University of Utah Hospitals and Clinics | Salt Lake City, Utah, 84132, United States
Hampton VA Hospital | Hampton, Virginia, 23667, United States
Richmond VA Medical Center (Hunter Holmes McGuire) | Richmond, Virginia, 23249, United States
CAMC Health Education & Research Institute | Charleston, West Virginia, 25304, United States
Foothills Provincial General Hospital | Calgary, Alberta, T2N 2T9, Canada
Glenrose Rehabilitation Hospital | Edmonton, Alberta, T5G 0B7, Canada
G.F. Strong Rehabilitation Centre | Vancouver, British Columbia, V5Z 2G9, Canada
Stan Cassidy Centre for Rehabilitation | Fredericton, New Brunswick, E3B 4R3, Canada
QEII HSC-Nova Scotia Rehabilitation Centre | Halifax, Nova Scotia, B3M 4K4, Canada
Parkwood Hospital Site, St. Joseph's Health Care | London, Ontario, N6C 5J1, Canada
The Rehabilitation Centre | Ottawa, Ontario, K1H 8M2, Canada
Toronto Rehabilitation Institute, Lyndhurst Centre | Toronto, Ontario, M5G 3V9, Canada
Standort Länder

Canada

United States

Überprüfungsdatum

April 2013

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: fampridine-SR 50mg/day

Art: Active Comparator

Etikette: Placebo

Art: Placebo Comparator

Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: Double (Participant, Investigator)

Quelle: ClinicalTrials.gov