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

NCT ID: NCT01356940

Last Updated: 2018-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-04-30

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

dalfampridine ER 10mg bid-placebo

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

Group Type: ACTIVE_COMPARATOR

dalfampridine ER

Intervention Type: DRUG

dalfampridine ER 10mg bid for 4 weeks

placebo

Intervention Type: DRUG

identical placebo tablet administered bid for four weeks

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

Group Type: PLACEBO_COMPARATOR

dalfampridine ER

Intervention Type: DRUG

dalfampridine ER 10mg bid for 4 weeks

placebo

Intervention Type: DRUG

identical placebo tablet administered bid for four weeks

Interventions

dalfampridine ER

dalfampridine ER 10mg bid for 4 weeks

Intervention Type: DRUG

placebo

identical placebo tablet administered bid for four weeks

Intervention Type: DRUG

Other Intervention Names

Ampyra serial number 77948545; Sugar Pill

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acorda Therapeutics

INDUSTRY

Sponsor Role: collaborator

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

INDIV

Sponsor Role: lead

Responsible Party

Theodore R Brown

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Theodore R Brown, MD

Role: PRINCIPAL_INVESTIGATOR

EvergreenHealth

Locations

MS Center at Evergreen

Kirkland, Washington, United States

Countries

United States

Other Identifiers

A randomized

Identifier Type: -

Identifier Source: org_study_id