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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
dalfampridine ER
placebo
Sponsored by
Brown, Theodore R., M.D., MPH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Ambulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • MS Center at Evergreen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

dalfampridine ER 10mg bid-placebo

placebo-dalfampridine ER 10mg bid

Arm Description

4 week administration of dalfampridine ER 10mg bid followed by 2 week washout and 4 weeks of placebo control

placebo tablet administered bid for four weeks followed by 2 week washout and 4 weeks of dalfampridine ER 10mg bid

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Stepcount
change in daily stepcount recorded by an accelerometer and averaged over 1 week of wear baseline vs 4 weeks

Full Information

First Posted
May 18, 2011
Last Updated
October 3, 2018
Sponsor
Brown, Theodore R., M.D., MPH
Collaborators
Acorda Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01356940
Brief Title
A Placebo Controlled Trial of Dalfampridine ER for Ambulatory Activity in People With Multiple Sclerosis
Official Title
A Randomized Controlled Double-blind Cross-over Trial of Dalfampridine ER for Effect on Ambulatory Activity in People With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown, Theodore R., M.D., MPH
Collaborators
Acorda Therapeutics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Ambulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dalfampridine ER 10mg bid-placebo
Arm Type
Active Comparator
Arm Description
4 week administration of dalfampridine ER 10mg bid followed by 2 week washout and 4 weeks of placebo control
Arm Title
placebo-dalfampridine ER 10mg bid
Arm Type
Placebo Comparator
Arm Description
placebo tablet administered bid for four weeks followed by 2 week washout and 4 weeks of dalfampridine ER 10mg bid
Intervention Type
Drug
Intervention Name(s)
dalfampridine ER
Other Intervention Name(s)
Ampyra serial number 77948545
Intervention Description
dalfampridine ER 10mg bid for 4 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
Sugar Pill
Intervention Description
identical placebo tablet administered bid for four weeks
Primary Outcome Measure Information:
Title
Peak Activity Index
Description
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
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Stepcount
Description
change in daily stepcount recorded by an accelerometer and averaged over 1 week of wear baseline vs 4 weeks
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theodore R Brown, MD
Organizational Affiliation
EvergreenHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
MS Center at Evergreen
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States

12. IPD Sharing Statement

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

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