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

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

Status and phase: Completed; Phase 4

Conditions: Multiple Sclerosis

Treatments: Drug: placebo; Drug: dalfampridine ER

Study type: Interventional

Funder types: Industry

Identifiers

NCT01356940

A randomized

Details and patient eligibility

About

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

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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43 participants in 2 patient groups, including a placebo group

dalfampridine ER 10mg bid-placebo

Active Comparator group

Description:

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

Treatment:

Drug: dalfampridine ER

Drug: placebo

placebo-dalfampridine ER 10mg bid

Placebo Comparator group

Description:

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

Treatment:

Drug: dalfampridine ER

Drug: placebo