A Placebo Controlled Trial of Dalfampridine ER for Ambulatory Activity in People With Multiple Sclerosis
What it found
The main measure did not show a significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Peak Activity Index | Mean Difference (Final Values) 0.586 | 0.586 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- dalfampridine ER
Placebo or sham
- placebo
Results by group
Peak Activity Index
10 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Dalfampridine ER 10mg Bid | 0.6 change in strides per minute | 0.54 (Standard Deviation) | 43 |
| Placebo | 0.3 change in strides per minute | 0.55 (Standard Deviation) | 42 |
Dalfampridine ER 10mg Bid
Placebo
p = 0.586; Mean Difference (Final Values) 0.586
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 ER 10mg Bid | 43 | 0 (0.0%) | |
| Placebo | 42 | 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
Peak Activity Index
10 weeks
Walking and mobility
Other measures (1)
Stepcount
10 weeks
Who could take part
MS (type not specified) · 18 to 75
Inclusion Criteria: * Diagnosis of MS made at least 3 months prior to based McDonald or Proser criteria. * Age 18-75 years old inclusive. * Expanded Disability Status Scale (EDS) 0-6.5 * Clinical stability defined as no MS exacerbation or change in disease modifying therapy for 60 days prior to screening. * Screening 6-minute walking test distance between 50m-500m, inclusive. * Written informed consent. Exclusion Criteria: * use of 4-aminopyridine within 6 months of screening * Any contraindication to DER: * Allergy to DER * history of seizure disorder or history of EEG showing epileptiform activity * Renal insufficiency (estimated GFR \< 60. * Any condition that would exclude 6 minute walking testing: * Cardiac surgery or myocardial infarction within the last 3 months. * Severe aortic stenosis or hypertropic cardiomyopathy. * Pulmonary embolus or infarction in the last 6 months. * Uncontrolled hypertension by history or by screening or baseline diastolic blood pressure > 170, or systolic blood pressure > 105. * Use of oxygen at home for 24 hours/day or severe lung disease. * History of ventricular arrhythmia or finding of significant ventricular arrhythmia. atrial arrhythmia or 2nd or 3rd degree heart block on screening ECG. * Concomitant neurological disease, such as ALS, Parkinson Disease, stroke. * Hospitalization in the last 6 months for psychiatric illness. * Alcohol or drug abuse within the past year. * Females who are breast-feeding, pregnant or have potential to become pregnant during the course of the study( fertile and unwilling/unable to use effective contraceptive measures) * Cognitive deficits that would interfere with the subject's ability to give informed consent or preform study testing. * Any other serious and/or unstable medical condition. * Use of mitoxantrone (Novantrone) within 6 months of baseline visit.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
A randomized placebo controlled double-blind cross-over trial of Dalfampridine ER for effect on ambulatory activity in people with multiple sclerosis
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History
Started
Nov 2010
Main results due
Apr 2013
Finished
Apr 2013
Results posted
Apr 2015
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