Expired Study
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Kirkland, Washington 98034


Purpose:

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


Study summary:

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.


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.


Study is Available At:


Original ID:

A randomized


NCT ID:

NCT01356940


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

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


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

43


Enrollment Type:

Actual


Overall Contact Information

Official Name:Theodore R Brown, MD
Principal Investigator
EvergreenHealth

Study Dates

Start Date:November 2010
Completion Date:April 2013
Completion Type:Actual
Primary Completion Date:April 2013
Primary Completion Type:Actual
Verification Date:October 2018
Last Changed Date:October 3, 2018
First Received Date:May 18, 2011
First Results Date:December 9, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Stepcount
Time Frame:10 weeks
Safety Issues:False
Description:change in daily stepcount recorded by an accelerometer and averaged over 1 week of wear baseline vs 4 weeks
Outcome Type:Primary Outcome
Measure:Peak Activity Index
Time Frame:10 weeks
Safety Issues:False
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

Study Interventions

Intervention Type:Drug
Name:placebo
Description:identical placebo tablet administered bid for four weeks
Arm Name:dalfampridine ER 10mg bid-placebo
Other Name:Sugar Pill
Intervention Type:Drug
Name:dalfampridine ER
Description:dalfampridine ER 10mg bid for 4 weeks
Arm Name:dalfampridine ER 10mg bid-placebo
Other Name:Ampyra serial number 77948545

Study Arms

Study Arm Type:Active Comparator
Arm Name:dalfampridine ER 10mg bid-placebo
Description:4 week administration of dalfampridine ER 10mg bid followed by 2 week washout and 4 weeks of placebo control
Study Arm Type:Placebo Comparator
Arm Name:placebo-dalfampridine ER 10mg bid
Description:placebo tablet administered bid for four weeks followed by 2 week washout and 4 weeks of dalfampridine ER 10mg bid

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Brown, Theodore R., M.D., MPH
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Acorda Therapeutics

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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