Efficacy of Dalfampridine on Upper Extremity Function in Patients With MS
Efficacy of Dalfampridine on Upper Extremity Function in Patients With MS
This study evaluates the effects of sustained-release oral dalfampridine in the treatment of
 upper limb deficits in people with multiple sclerosis (MS). In this double-blind randomized
 pilot study half of participants will dalfampridine, while the other half will receive a
 placebo.
Dalfampridine (ampyra), a drug with a mechanism for symptomatic management of MS among blocks
 potassium channels on demyelinated neurons, allows normal electrical conduction.

 Dalfampridine has recently been found to be associated with improvements in visual function,
 strength, ambulation, fatigue, and endurance in individuals with MS.

 Although this medication has a widespread effect, its influence on upper extremity function
 has never been investigated in a double blind randomized case control study.

 Following the fact that during the disease course, approximately 3 out of 4 multiple
 sclerosis patients encounter upper limb dysfunction the primary objective of this study will
 be to investigate the efficacy of sustained-release oral dalfampridine on upper extremity
 function in patients with MS.
Inclusion Criteria:

 1. The patient must have the ability to understand the purpose and risks of the study
 provide a signed and dated informed consent and authorize confidential health
 information to be examined in accordance with national and local subject privacy
 regulations.

 2. The patient must have been diagnosed with clinically definite MS, at the time of
 informed consent.

 3. The patient must be between 18-70 years of age, inclusive, at the time of informed
 consent.

 4. The patient must have scored between 50 and 90 on the upper limb Motricity Index test,
 at the time of informed consent. This test evaluates strength during three essential
 movements (pinch grasp, elbow flexion and shoulder abduction). The selected score
 range criteria determine patients who suffer a moderate decline in function abilities
 of the upper limb.

 Exclusion Criteria:

 1. Onset of multiple sclerosis exacerbation within 60 days of screening.

 2. History of seizures or evidence of epileptic form activity found on a screened
 electroencephalogram.

 3. Changes in concomitant medications to avoid related changes in multiple sclerosis
 symptoms during the study.