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

• Change from baseline in Ashworth score evaluating spasticity [ Time Frame: Baseline stable dose treatment (Average of days 7-14) and baseline double blind treatment period (average of days 28-98) ] [ Designated as safety issue: No ]
  The Ashworth score is the average rating by the clinician of four lower extremity muscle groups (left and right knee flexors and extensors), each evaluated on a 1-5 unit ordinal scale
• Change from baseline in Subject's Global Impression (SGI) of treatment [ Time Frame: Baseline stable dose treatment (Average of days 7-14) and baseline double blind treatment period (average of days 28-98) ] [ Designated as safety issue: No ]
  The SGI is a 7-unit ordinal scale used by the subject to evaluate the effects of study medication on his/her quality of life during the preceding week, with higher scores denoting greater satisfaction. A positive change score in SGI signifies improved outcome

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.

• Spinal Cord Injury
• Muscle Spasticity

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

• Active Comparator: fampridine-SR 50mg/day
  Intervention: Drug: Fampridine-SR
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

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