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

Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00041717
• Other study ID #: SCI-F301
• Status: Completed
• Phase: Phase 3
• Start date: July 2002
• Est. completion date: May 2004

Study information

• Verified date: April 2013
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: May 2004
• Est. primary completion date: February 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Drug:
• Fampridine-SR
25mg bid (twice daily)

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	Foothills Provincial General Hospital	Calgary	Alberta
Canada	Glenrose Rehabilitation Hospital	Edmonton	Alberta
Canada	Stan Cassidy Centre for Rehabilitation	Fredericton	New Brunswick
Canada	QEII HSC-Nova Scotia Rehabilitation Centre	Halifax	Nova Scotia
Canada	Parkwood Hospital Site, St. Joseph's Health Care	London	Ontario
Canada	The Rehabilitation Centre	Ottawa	Ontario
Canada	Toronto Rehabilitation Institute, Lyndhurst Centre	Toronto	Ontario
Canada	G.F. Strong Rehabilitation Centre	Vancouver	British Columbia
United States	Good Shepherd Rehabilitation	Allentown	Pennsylvania
United States	Shepherd Spinal Center	Atlanta	Georgia
United States	Lakeshore Rehabilitation Hospital	Birmingham	Alabama
United States	Clinical Research Services	Bismarck	North Dakota
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts
United States	HEALTHSOUTH Braintree Rehabilitation Hospital	Braintree	Massachusetts
United States	UNC Chapel Hill	Chapel Hill	North Carolina
United States	CAMC Health Education & Research Institute	Charleston	West Virginia
United States	Rehabilitation Institute of Chicago	Chicago	Illinois
United States	Drake Center	Cincinnati	Ohio
United States	Cleveland VAMC	Cleveland	Ohio
United States	Mary Free Bed Hospital & Rehabilitation Center	Grand Rapids	Michigan
United States	East Carolina University	Greenville	North Carolina
United States	Hampton VA Hospital	Hampton	Virginia
United States	Baptist Medical Center	Little Rock	Arkansas
United States	Bryn Mawr Rehabilitation Hospital	Malvern	Pennsylvania
United States	Miami Center to Cure Paralysis at the Univ. of Miami School of Medicine	Miami	Florida
United States	Montana Neuroscience	Missoula	Montana
United States	Advocate Christ Medical Center-Dept. of Physical Medicine & Rehabilitation-EMG	Oak Lawn	Illinois
United States	VA Palo Alto Health Care System	Palo Alto	California
United States	Neuro-Therapeutics, Inc	Pasadena	California
United States	Barrow Neurological Institute	Phoenix	Arizona
United States	HEALTHSOUTH Harmarville Rehabilitation Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Richmond VA Medical Center (Hunter Holmes McGuire)	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University School of Medicine, Div. of Rehab/Neurology	Saint Louis	Missouri
United States	Rehabilitation Services University of Utah Hospitals and Clinics	Salt Lake City	Utah
United States	Northeastern Rehabilitation Associates	Scranton	Pennsylvania
United States	Springfield Clinic-Neuroscience Institute	Springfield	Illinois
United States	Rehabilitation Hospital	Sunrise	Florida
United States	National Rehabilitation Hospital	Washington	District of Columbia
United States	Kessler Institute of Rehabilitation	West Orange	New Jersey
United States	The Burke Rehabilitation Hospital	White Plains	New York
United States	Neurology Associates, P.A.	Wilmington	Delaware
United States	Wake Forest University	Winston-Salem	North Carolina
United States	HEALTHSOUTH New England Rehabilitation Hospital	Woburn	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity	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
Primary	Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment	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

External Links

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