Clinical trial NCT00041717: Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinal Cord Injury
Muscle Spasticity
Keywords: spinal cord injury
muscle spasticity
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2002-07-16
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity
timeFrame: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
measure: Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment
timeFrame: Baseline (visits 2,3) average score days 7,14 and double blind treatment period (visits 4-7) average score days 28-98
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Lakeshore Rehabilitation Hospital
state: Alabama
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Little Rock
country: United States
facility: Baptist Medical Center
state: Arkansas
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: Pasadena
country: United States
facility: Neuro-Therapeutics, Inc
state: California
city: Wilmington
country: United States
facility: Neurology Associates, P.A.
state: Delaware
city: Washington
country: United States
facility: National Rehabilitation Hospital
state: District of Columbia
city: Miami
country: United States
facility: Miami Center to Cure Paralysis at the Univ. of Miami School of Medicine
state: Florida
city: Sunrise
country: United States
facility: Rehabilitation Hospital
state: Florida
city: Atlanta
country: United States
facility: Shepherd Spinal Center
state: Georgia
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center-Dept. of Physical Medicine & Rehabilitation-EMG
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic-Neuroscience Institute
state: Illinois
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
city: Braintree
country: United States
facility: HEALTHSOUTH Braintree Rehabilitation Hospital
state: Massachusetts
city: Woburn
country: United States
facility: HEALTHSOUTH New England Rehabilitation Hospital
state: Massachusetts
city: Grand Rapids
country: United States
facility: Mary Free Bed Hospital & Rehabilitation Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine, Div. of Rehab/Neurology
state: Missouri
city: Missoula
country: United States
facility: Montana Neuroscience
state: Montana
city: West Orange
country: United States
facility: Kessler Institute of Rehabilitation
state: New Jersey
city: White Plains
country: United States
facility: The Burke Rehabilitation Hospital
state: New York
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Bismarck
country: United States
facility: Clinical Research Services
state: North Dakota
city: Cincinnati
country: United States
facility: Drake Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland VAMC
state: Ohio
city: Allentown
country: United States
facility: Good Shepherd Rehabilitation
state: Pennsylvania
city: Malvern
country: United States
facility: Bryn Mawr Rehabilitation Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Pittsburgh
country: United States
facility: HEALTHSOUTH Harmarville Rehabilitation Hospital
state: Pennsylvania
city: Scranton
country: United States
facility: Northeastern Rehabilitation Associates
state: Pennsylvania
city: Salt Lake City
country: United States
facility: Rehabilitation Services University of Utah Hospitals and Clinics
state: Utah
city: Hampton
country: United States
facility: Hampton VA Hospital
state: Virginia
city: Richmond
country: United States
facility: Richmond VA Medical Center (Hunter Holmes McGuire)
state: Virginia
city: Charleston
country: United States
facility: CAMC Health Education & Research Institute
state: West Virginia
city: Calgary
country: Canada
facility: Foothills Provincial General Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Glenrose Rehabilitation Hospital
state: Alberta
city: Vancouver
country: Canada
facility: G.F. Strong Rehabilitation Centre
state: British Columbia
city: Fredericton
country: Canada
facility: Stan Cassidy Centre for Rehabilitation
state: New Brunswick
city: Halifax
country: Canada
facility: QEII HSC-Nova Scotia Rehabilitation Centre
state: Nova Scotia
city: London
country: Canada
facility: Parkwood Hospital Site, St. Joseph's Health Care
state: Ontario
city: Ottawa
country: Canada
facility: The Rehabilitation Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute, Lyndhurst Centre
state: Ontario
Study officials:
affiliation: Acorda Therapeutics
name: Andrew Blight
role: STUDY_DIRECTOR
References: