A Placebo Controlled Trial of Dalfampridine ER for Ambulatory Activity in People With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: dalfampridine ER; placebo
Intervention description: dalfampridine ER 10mg bid for 4 weeks; identical placebo tablet administered bid for four weeks
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Ambulation

Summary:

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

Eligibility 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.