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

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brown, Theodore R., M.D., MPH
• Collaborator: Acorda Therapeutics
• Treatments: 4-Aminopyridine

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.