Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multi
Double-Blind, Placebo-Controlled, 20-Week, Parallel Group Study to Evaluate Safety, Tolerability and Activity of Oral Fampridine-SR in Subjects With Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Dalfampridine
Voltage-gated potassium channel blocker
Placebo
- Placebo
Results by group
Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test
Baseline (placebo run-in period); 12-week stable dose period
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo | 1.2 percent change | -37.6–60.4 | 47 |
| 10 mg Fampridine Twice a Day (b.i.d.) | 7.5 percent change | -38.9–103 | 52 |
| 15 mg Fampridine b.i.d. | 9.7 percent change | -55.5–97.6 | 50 |
| 20 mg Fampridine b.i.d. | 6.9 percent change | -40–81.4 | 57 |
Placebo
10 mg Fampridine Twice a Day (b.i.d.)
15 mg Fampridine b.i.d.
20 mg Fampridine b.i.d.
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Placebo | 47 | 2 (4.3%) | |
| 10 mg Fampridine Twice a Day (b.i.d.) | 52 | 0 (0.0%) | |
| 15 mg Fampridine b.i.d. | 50 | 4 (8.0%) | |
| 20 mg Fampridine b.i.d. | 57 | 7 (12.3%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Median Percent Change From Baseline in Average Walking Speed on Timed 25-Foot Walk Test
Baseline (placebo run-in period); 12-week stable dose period
Disability progressionWalking and mobility
Who could take part
MS (type not specified) · 18 to 70
Show the full criteria
Inclusion criteria
* Have a confirmed diagnosis of Multiple Sclerosis * Are able to walk with or without an assisted device
Exclusion criteria
* Pregnancy, breastfeeding or females of childbearing potential not using adequate birth control * Participating in other investigational drug trials * A medical history or clinical findings that preclude entry into the study * A medication history that precludes entry into the study * Previously treated with 4-aminopyridine (4-AP)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the Central Nervous System (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR (Sustained Release, SR) is an experimental drug that increases the ability of the nerve to conduct electrical impulses. This study will evaluate the effects of Fampridine-SR on the walking ability of subjects with MS, as well as to examine the effects on muscle strength and spasticity. The study will also examine the possible risks of taking Fampridine-SR.
Papers
Loading reviews and guidelines…
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History
Started
Feb 2003
Main results due
Dec 2003
Finished
Dec 2003
Results posted
Aug 2011