At a glance
ClinicalIndex Comparison Record- ✓Incomplete traumatic spinal cord injury of at least 18 months duration, stable for at least 6 months
- ✓Moderate to severe lower-limb spasticity
- ✓Able to provide 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
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Fampridine-SR and Placebo for Spinal Cord Injury and Muscle Spasticity. Completed, enrolled 213 participants across 45 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
25mg bid (twice daily)
Placebo