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

Completed · Phase 4 · Has a placebo group

Conditions studied: Multiple Sclerosis

In brief

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

Key facts

Study ID

NCT01356940

Run by

Brown, Theodore R., M.D., MPH

People needed

43

Starts

2010-11-01

Expected to finish

2013-04-01

Last updated by the study team

2018-10-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• MS Center at Evergreen — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

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