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

A Randomized Controlled Double-blind Cross-over Trial of Dalfampridine ER for Effect on Ambulatory Activity in People With Multiple Sclerosis

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: dalfampridine ER; Drug: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Washington
    • Kirkland, Washington, United States, 98034
      • MS Center at Evergreen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Ampyra serial number 77948545; Drug: placebo; identical placebo tablet administered bid for four weeks; Other Names: 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 Names: Ampyra serial number 77948545; Drug: placebo; identical placebo tablet administered bid for four weeks; Other Names: Sugar Pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Activity Index	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	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stepcount	change in daily stepcount recorded by an accelerometer and averaged over 1 week of wear baseline vs 4 weeks	10 weeks

Collaborators and Investigators

• Sponsor: Brown, Theodore R., M.D., MPH
• Collaborators: Acorda Therapeutics
• Investigators: Principal Investigator: Theodore R Brown, MD, EvergreenHealth

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: May 18, 2011
• First Submitted That Met QC Criteria: May 19, 2011
• First Posted (Estimate): May 20, 2011

Study Record Updates

• Last Update Posted (Actual): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 3, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Ambulation
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Potassium Channel Blockers; 4-Aminopyridine
• Other Study ID Numbers: A randomized