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

This study has been completed.
Sponsor:
Collaborator:
Acorda Therapeutics
Information provided by (Responsible Party):
Theodore R Brown, Brown, Theodore R., M.D., MPH
ClinicalTrials.gov Identifier:
NCT01356940
First received: May 18, 2011
Last updated: April 8, 2015
Last verified: April 2015
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356940

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

No publications provided

Responsible Party: Theodore R Brown, Principle Investigator, Brown, Theodore R., M.D., MPH
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
4-Aminopyridine
Cardiovascular Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Potassium Channel Blockers
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2015