Dalfampridine for Imbalance in Multiple Sclerosis
Dalfampridine to Improve Imbalance in Multiple Sclerosis: A Pilot Study
What it found
The main measure did not show a significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Change in Automatic Postural Response (APR )Latency | 0.51 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Dalfampridine
Voltage-gated potassium channel blocker
Placebo
- Placebo
Results by group
Change in Automatic Postural Response (APR )Latency
Baseline to 12 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Dalfampridine | 5.71 milliseconds | 16.2 (Standard Deviation) | 8 |
| Placebo | 4.58 milliseconds | 23 (Standard Deviation) | 12 |
Dalfampridine
Placebo
p = 0.51
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Dalfampridine | 12 | 0 (0.0%) | |
| Placebo | 12 | 0 (0.0%) |
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
Change in Automatic Postural Response (APR )Latency
Baseline to 12 weeks
Disability progressionMyelin repairWalking and mobility
Other measures (2)
Change in Activities-specific Balance Confidence (ABC) Questionnaire Scores
Baseline to 12 weeks
Walking and mobilityChange in Timed 25 Foot Walking Speed
Baseline to 12 weeks
Disability progressionWalking and mobility
Who could take part
MS (type not specified) · 20 to 59
Show the full criteria
Inclusion criteria
* Age 20- 59 years, * Able to walk at least 100m without an aide or with unilateral assistance * Prolonged APR latencies (≥ 1SD > mean for healthy people in this age range) OR, * Reduced balance-related activity (ABC scores ≤ 85%), * Abnormal trunk range of motion (horizontal), trunk range of motion (frontal), turning duration, cadence, double support time, stride length or gait cycle time (outside 1SD of the average for healthy people in this age range)
Exclusion criteria
* Currently taking dalfampridine (any within the last 2 weeks), * Cause(s) of imbalance other than MS, * Impaired renal function (creatinine clearance ≤50mL/min), * Seizure disorder * Pregnancy or breast feeding
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Dalfampridine is a new medication that was FDA approved in 2010 to improve walking speed in people with Multiple Sclerosis (MS). People with MS walk slowly in part because MS damages the myelin insulation around nerves which slows conduction of messages from the brain to the leg muscles. Dalfampridine works by improving conduction in nerves with damaged myelin. Recent research indicates that imbalance in MS is in large part caused by poor conduction by the nerves that transmit information about the position of the legs to the brain. It is therefore likely that, by improving nerve conduction, dalfampridine will also improve imbalance in people with MS. Dalfampridine will be administered in this study by the same route (oral), dosage (10mg), and frequency (every 12 hours) approved by the FDA to improve walking speed in people with MS. The proposed pilot study will examine the effects of dalfampridine on imbalance in 24 subjects with Multiple Sclerosis (MS) and imbalance. This small pilot study will help to show if dalfampridine improves imbalance in MS and will guide the design and implementation of a larger full scale study to definitively determine if dalfampridine improves balance and prevents falls in people with MS.
Papers
Loading reviews and guidelines…
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History
Started
Sept 2011
Main results due
Sept 2013
Finished
Sept 2013
Results posted
Jun 2014