Phase 3
N=204
Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury
Spinal Cord Injury · Muscle Spasticity
Bottom Line
View on ClinicalTrials.gov: NCT01683838 ↗Enrolled (actual)
204
Serious AEs
8.4%
Results posted
Feb 2014
Primary outcome: Primary: Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity — -0.28; -0.16 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fampridine-SR (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Acorda Therapeutics
- Primary completion
- Nov 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity |
-0.28; -0.16 | — |
| PRIMARY Double-blind Change From Baseline in Mean Subject's Global Impression (SGI) Scores |
-0.0; 0.1 | — |
| SECONDARY Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores |
-0.13; 0.02; -0.12; -0.10; -0.09; -0.02 | — |
| SECONDARY Double-blind Change From Baseline in Mean Clinician's Global Impression (CGI) Scores |
-0.2; -0.2 | — |
| SECONDARY Stable-dose Change From Baseline in Mean American Spinal Injury Association(ASIA) Total Motor Score |
0.4; 0.7 | — |
| SECONDARY Change From Baseline in Mean International Index of Erectile Function (IIEF) Score |
0.8; 1.6; 0.3; 0.0; -0.0; 0.0 | — |
| SECONDARY Change From Baseline in Mean Female Sexual Function Index (FSFI) Scores |
0.7; 0.2; 0.6; 0.2; 0.7; -0.2 | — |
| SECONDARY Adjusted Mean Change in Subject Bladder/Bowel Function Diary Scores |
-0.2; -0.2; 0.1; -0.0 | — |
| SECONDARY Adjusted Mean Change in Subject Bowel Function Diary Scores |
-0.7; 0.3 | — |
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
Data sourced from ClinicalTrials.gov (NCT01683838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.