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

This study has been completed.
Acorda Therapeutics
Information provided by (Responsible Party):
Theodore R Brown, Brown, Theodore R., M.D., MPH Identifier:
First received: May 18, 2011
Last updated: April 8, 2015
Last verified: April 2015
A randomized placebo controlled double-blind cross-over trial of Dalfampridine ER for effect on ambulatory activity in people with multiple sclerosis

Condition Intervention Phase
Multiple Sclerosis
Drug: dalfampridine ER
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Double-blind Cross-over Trial of Dalfampridine ER for Effect on Ambulatory Activity in People With Multiple Sclerosis

Resource links provided by NLM:

Further study details as provided by Brown, Theodore R., M.D., MPH:

Primary Outcome Measures:
  • Peak Activity Index [ Time Frame: 10 weeks ]
    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

Secondary Outcome Measures:
  • Stepcount [ Time Frame: 10 weeks ]
    daily stepcount recorded by an accelerometer and averaged over 1 week of wear

Enrollment: 43
Study Start Date: November 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: dalfampridine ER 10mg bid-placebo
4 week administration of dalfampridine ER 10mg bid followed by 2 week washout and 4 weeks of placebo control
Drug: dalfampridine ER
dalfampridine ER 10mg bid for 4 weeks
Other Name: Ampyra serial number 77948545
Drug: placebo
identical placebo tablet administered bid for four weeks
Other Name: Sugar Pill
Placebo Comparator: placebo-dalfampridine ER 10mg bid
placebo tablet administered bid for four weeks followed by 2 week washout and 4 weeks of dalfampridine ER 10mg bid
Drug: dalfampridine ER
dalfampridine ER 10mg bid for 4 weeks
Other Name: Ampyra serial number 77948545
Drug: placebo
identical placebo tablet administered bid for four weeks
Other Name: Sugar Pill

Detailed Description:
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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01356940

United States, Washington
MS Center at Evergreen
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
Brown, Theodore R., M.D., MPH
Acorda Therapeutics
Principal Investigator: Theodore R Brown, MD EvergreenHealth
  More Information

Responsible Party: Theodore R Brown, Principle Investigator, Brown, Theodore R., M.D., MPH Identifier: NCT01356940     History of Changes
Other Study ID Numbers: A randomized
Study First Received: May 18, 2011
Results First Received: December 9, 2014
Last Updated: April 8, 2015

Keywords provided by Brown, Theodore R., M.D., MPH:

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017