Efficacy and Safety of 4-aminopyridine on Cognitive Performance and Motor Function of Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Twenty four relapsing-remitting multiple sclerosis (RRMS) patients over the age of 18, with
      similar degree of disability, and with an evolution of at last 6 months, who are in
      first-line immunomodulatory therapy and have a stable disease (no more than one outbreak per
      year) will be included in the present study. Patients will be administered a
      neuropsychological test battery selected for this study and divided into two sessions of one
      and a half-hour each. Emotional state will be assessed with the Beck Depression Inventory in
      a different session. Cognitive impairment is defined as the alteration of two or more
      neuropsychological tests. Patients will be divided randomly into two groups where one will
      receive placebo and the other one 4-Aminopyridine (4-AP) for a period of 22 weeks in
      increasing doses.
    

Detailed description: 
      Consecutive patients with stable multiple sclerosis are being recruited from the neurological
      services of Social Security Mexican Institute (IMSS) at the National Medical Center (CMN)
      "Siglo XXI" Specialties Hospital over the period of 1 year. Of those meeting inclusion
      criteria, 24 will be selected for the study. After signing an informed consent, they will be
      randomized into 12 for the intervention arm and 12 for the placebo arm. All patients will
      receive capsules for daily consumption according to their assignment, with no visible
      difference between capsules. Dosage will be 6.5-7.5 mg/kg to a limit of 50 mg. These capsules
      will be taken for a period of 22 weeks. A battery of neuropsychological tests will be
      administered at baseline, after 22 weeks, and after an additional 22 weeks of follow-up to
      assess cognitive performance and motor function. Emotional state will be assessed with the
      Beck Depression Inventory at each of the three afore mentioned points.

      After the follow-up period, all test results will be analyzed and compared to determine the
      efficacy and safety of 4-aminopyridine on the cognitive performance and motor function of
      patients. Mann-Whitney U will be used for statistical analysis.
    

Intervention name(s): 4-aminopyridine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Each patient will take two capsules every 8 hours after meals, for a total of 6 capsules/day. The 4-aminopyridine dosage will increase 10 mg/4 weeks by substitution of placebo instead of 4-aminopyridine capsules; such that patients will receive from 40 to 60 mg. distribute in 6capsules/day throughout the study.; The placebo arm will include Microcrystalline Cellulose placebo
Other intervention name(s): 4-AP; Microcrystalline Cellulose
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive function; Multiple sclerosis; 4-aminopyridine; Fatigue