Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury
- Conditions
- Spinal Cord InjuryMuscle Spasticity
- Interventions
- Drug: Fampridine-SROther: Placebo
- Registration Number
- NCT00041717
- Lead Sponsor
- Acorda Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 213
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description fampridine-SR 50mg/day Fampridine-SR - Placebo Placebo -
- Primary Outcome Measures
Name Time Method 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 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.
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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (45)
Lakeshore Rehabilitation Hospital
🇺🇸Birmingham, Alabama, United States
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
Baptist Medical Center
🇺🇸Little Rock, Arkansas, United States
VA Palo Alto Health Care System
🇺🇸Palo Alto, California, United States
Neuro-Therapeutics, Inc
🇺🇸Pasadena, California, United States
Neurology Associates, P.A.
🇺🇸Wilmington, Delaware, United States
National Rehabilitation Hospital
🇺🇸Washington, District of Columbia, United States
Miami Center to Cure Paralysis at the Univ. of Miami School of Medicine
🇺🇸Miami, Florida, United States
Rehabilitation Hospital
🇺🇸Sunrise, Florida, United States
Shepherd Spinal Center
🇺🇸Atlanta, Georgia, United States
Scroll for more (35 remaining)Lakeshore Rehabilitation Hospital🇺🇸Birmingham, Alabama, United States