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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

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City:   Kirkland
State:   Washington
Zip Code:   98034
Conditions:   Multiple Sclerosis
Purpose:   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.
Study Summary:  
Criteria:   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.
NCT ID:   NCT01356940
Primary Contact:   N/A
Backup Contact:   N/A
Location Contact:   Kirkland, Washington 98034
United States



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Site Status: N/A

Data Source:   ClinicalTrials.gov
Date Processed:   April 24, 2014
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