Clinical trial NCT01683838: Safety and Efficacy of Oral Fampridine-Sustained Release (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: 2012-09-12
Enrollment: 204
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 Mean Subject's Global Impression (SGI) Scores
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:
measure: Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores
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 Mean Clinician's Global Impression (CGI) Scores
timeFrame: Baseline (visits 2,3) average of days 7-14 and double-blind treatment period (visits 4-7) average of days 28-98)
measure: Stable-dose Change From Baseline in Mean American Spinal Injury Association(ASIA) Total Motor Score
timeFrame: Baseline (visits 2,3) average score days 7,14 and stable-dose treatment period (visits 5-7) average score days 56-98
measure: Change From Baseline in Mean International Index of Erectile Function (IIEF) Score
timeFrame: Baseline (visit 1) average score obtained at day 1 and stable treatment period (visit 7) average score day 98
measure: Change From Baseline in Mean Female Sexual Function Index (FSFI) Scores
timeFrame: Baseline (visit 1) average score obtained at day 1 and stable treatment period (visits 4-7) average score days 28-98
measure: Adjusted Mean Change in Subject Bladder/Bowel Function Diary Scores
timeFrame: Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98
measure: Adjusted Mean Change in Subject Bowel Function Diary Scores
timeFrame: Baseline (visit 1) average score obtained at day 1 and double-blind treatment period (visits 4-7) average score days 28-98
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB School of Medicine, 190 Spain Rehab Center
state: Alabama
city: Long Beach
country: United States
facility: Long Beach VA Medical Center
state: California
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
city: New Britain
country: United States
facility: Hospital for Special Care
state: Connecticut
city: Hines
country: United States
facility: Hines VA Hospital
state: Illinois
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Rehabilitation Institute of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis VA Hospital
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis University
state: Missouri
city: Rochester
country: United States
facility: University of Rochester/Strong Memorial Hospital
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Clinical Trials Office
state: New York
city: West Haverstraw
country: United States
facility: Helen Hayes Hospital
state: New York
city: Charlotte
country: United States
facility: Charlotte Institute of Rehabilitation
state: North Carolina
city: Wilmington
country: United States
facility: Coastal AHEC
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Dayton
country: United States
facility: Miami Valley Hospital- Rehabilitation Institute of Medicine
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: VA North Texas Health Care System
state: Texas
city: Dallas
country: United States
facility: Southwestern Medical Center at Dallas
state: Texas
city: Falls Church
country: United States
facility: INOVA Institute of Research and Education
state: Virginia
city: Richmond
country: United States
facility: Medical College of Virginia/VCU
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center, Dept. of Rehabilitation
state: Washington
city: Milwaukee
country: United States
facility: Wood VA Medical Center
state: Wisconsin
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Hamilton
country: Canada
facility: Chedoke-McMaster Hospital
state: Ontario
city: Kingston
country: Canada
facility: St. Mary's of the Lake Hospital
state: Ontario
Study officials:
affiliation: Acorda Therapeutics
name: Andrew Blight, MD
role: STUDY_DIRECTOR
References: