Clinical trial NCT01356940: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Keywords: Ambulation
Lead sponsor: Brown, Theodore R., M.D., MPH
Sponsor class: INDIV
Collaborators: name: Acorda Therapeutics
First posted: 2011-05-20
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Peak Activity Index
timeFrame: 10 weeks
Secondary outcomes:
measure: Stepcount
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Kirkland
country: United States
facility: MS Center at Evergreen
state: Washington
Study officials:
affiliation: EvergreenHealth
name: Theodore R Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: