A Placebo Controlled Trial of Dalfampridine ER for Ambulatory Activity in People With Multiple Sclerosis

Study Overview
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Brief Summary
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A randomized placebo controlled double-blind cross-over trial of Dalfampridine ER for effect on ambulatory activity in people with multiple sclerosis

Detailed Description
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This is a parallel-group, double-blind, randomized controlled crossover trial with a 1:1 randomization. There are two treatment periods of 4 weeks and a two-week off treatment washout period. Treatment periods are DER (dalfampridine ER) followed by placebo (group A) and placebo followed by DER (group B), respectively. All dosages will be administered twice a week. Purpose of the study is to see if using the study drug(dalfampridine Er) for a short period of time will improve the way subjects with multiple sclerosis (MS) walk.

Official Title
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A Randomized Controlled Double-blind Cross-over Trial of Dalfampridine ER for Effect on Ambulatory Activity in People With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: dalfampridine ER
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dalfampridine ER 10mg bid-placebo<br>4 week administration of dalfampridine ER 10mg bid followed by 2 week washout and 4 weeks of placebo control | Drug: dalfampridine ER<br>* dalfampridine ER 10mg bid for 4 weeks<br>* Other names: Ampyra serial number 77948545;Drug: placebo<br>* identical placebo tablet administered bid for four weeks<br>* Other names: Sugar Pill;|
| Placebo Comparator: placebo-dalfampridine ER 10mg bid<br>placebo tablet administered bid for four weeks followed by 2 week washout and 4 weeks of dalfampridine ER 10mg bid | Drug: dalfampridine ER<br>* dalfampridine ER 10mg bid for 4 weeks<br>* Other names: Ampyra serial number 77948545;Drug: placebo<br>* identical placebo tablet administered bid for four weeks<br>* Other names: Sugar Pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Activity Index | peak activity index is a measure of the 30 fastest minutes of walking over a 24 hour period, averaged over one week of accelerometer wear. Measurement is change from baseline to 4 weeks on intervention | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stepcount | change in daily stepcount recorded by an accelerometer and averaged over 1 week of wear baseline vs 4 weeks | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ambulation