Study of Fampridine-SR Tablets in Multiple Sclerosis Patients
What it found
The main measure showed a statistically significant benefit.
“The proportion of TWRs was higher in the dalfampridine group (51/119 or 42.9%) compared to the placebo group (11/118 or 9.3%, p < 0.0001).”Read by software from the paper's abstract
9 weeks of treatment
| Group | n | Value |
|---|---|---|
| Placebo | 119 | 11/118 or 9.3% |
p = < 0.0001
Read by software from the paper's abstract
What was tested
Treatment tested
- Dalfampridine
Voltage-gated potassium channel blocker
Placebo or sham
- Placebo
Results by group
Responders Based Upon the Timed 25-Foot Walk [T25FW]
Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fampridine-SR 10 mg b.i.d. Treatment | 51 participants | 119 | |
| Placebo Treatment | 11 participants | 118 |
Fampridine-SR 10 mg b.i.d. Treatment
Placebo Treatment
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Fampridine-SR 10 mg b.i.d. Treatment | 120 | 5 (4.2%) | |
| Placebo Treatment | 119 | 3 (2.5%) |
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
Responders Based Upon the Timed 25-Foot Walk [T25FW]
Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77
Disability progressionWalking and mobility
Other measures (1)
Change in Lower Extremity Manual Muscle Test [LEMMT]
Days -21, -14, -7, 0, 14, 28, 42, 56, 63, 77
Physical function
Who could take part
MS (type not specified) · 18 to 70
Inclusion Criteria: * Patient with clinically defined multiple sclerosis * All patients must be able to complete two trials of a timed 25 foot walk Exclusion Criteria: * Female patients who are either pregnant or breastfeeding.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of the study is to show that individuals treated with Fampridine-SR tablets are significantly more likely to have consistent improvements in their walking than those treated with placebo tablets.
Papers
Results
Goodman AD, Brown TR, Edwards KR, Krupp LB, Schapiro RT, Cohen R, Marinucci LN, Blight AR; MSF204 Investigators. A phase 3 trial of extended release oral dalfampridine in multiple sclerosis. Ann Neurol. 2010 Oct;68(4):494-502. doi: 10.1002/ana.22240.The proportion of TWRs was higher in the dalfampridine group (51/119 or 42.9%) compared to the placebo group (11/118 or 9.3%, p < 0.0001).
Read by software from the paper's abstract
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History
Started
May 2007
Main results due
Feb 2008
Finished
May 2008
Results posted
Apr 2011
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