Study of Oral Fampridine-SR in Multiple Sclerosis
What it found
The main measure showed a statistically significant benefit.
“The proportion of timed walk responders was higher in the fampridine group (78/224 or 35%) than in the placebo group (6/72 or 8%; p<0.0001).”Read by software from the paper's abstract
14 weeks
| Group | n | Value |
|---|---|---|
| Placebo | 72 | 6/72 or 8% |
p = <0.0001
Total participants: 301
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
Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)
Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo- Sugar Pill | 6 Participants | 72 | |
| Fampridine-SR | 78 Participants | 224 |
Placebo- Sugar Pill
Fampridine-SR
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- Sugar Pill | 72 | 0 (0.0%) | |
| Fampridine-SR | 228 | 16 (7.0%) |
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
Timed Walk Responders (Patients Who Showed Consistent Improvement on the Timed-25 Foot Walk)
Days 14, 42, 70 and 98 of treatment, corresponding to the four on-drug visits during double-blind treatment period.
Walking and mobility
Other measures (1)
Lower Extremity Manual Muscle Test; Ashworth Score for Spasticity
Days 14, 42, 70, 98
Spasticity
Who could take part
MS (type not specified) · 18 to 70
Inclusion Criteria: * Have a confirmed diagnosis of multiple sclerosis * Are able to walk with or without an assistive 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
To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled, parallel group study.
Papers
Results
Estimation of the effect of dalfampridine-ER on health utility by mapping the MSWS-12 to the EQ-5D in multiple sclerosis patients.Health Qual Life Outcomes · 2013
Results
Sustained-release oral fampridine in multiple sclerosis: a randomised, double-blind, controlled trial.Lancet · 2009
The proportion of timed walk responders was higher in the fampridine group (78/224 or 35%) than in the placebo group (6/72 or 8%; p<0.0001).
Read by software from the paper's abstract
Loading reviews and guidelines…
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History
Started
May 2005
Main results due
Jun 2006
Finished
Sept 2006
Results posted
May 2011
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