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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356940
• Other study ID #: A randomized
• Status: Completed
• Phase: Phase 4
• Start date: November 2010
• Est. completion date: April 2013

Study information

• Verified date: October 2018
• Source: Brown, Theodore R., M.D., MPH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• dalfampridine ER
dalfampridine ER 10mg bid for 4 weeks
• placebo
identical placebo tablet administered bid for four weeks

Locations

Country	Name	City	State
United States	MS Center at Evergreen	Kirkland	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Brown, Theodore R., M.D., MPH	Acorda Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Stepcount	change in daily stepcount recorded by an accelerometer and averaged over 1 week of wear baseline vs 4 weeks	10 weeks