Status:
COMPLETED
Efficacy and Safety of 4-aminopyridine on Cognitive Performance and Motor Function of Patients With Multiple Sclerosis
Lead Sponsor:
Coordinación de Investigación en Salud, Mexico
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 immunomodulat...
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" Spec...
Eligibility Criteria
Inclusion
- Patients with multiple sclerosis (MS) are eligible for the study if they meet the following criteria:
- Relapsing recurrent MS with an evolution of at last 6 months before the study began.
- Both males and females, aged 20 - 65 years
- Neurologic Expanded Disability Status Scale (EDSS) 3 - 7
- Who are in first-line immunomodulatory therapy and have a stable disease
- No more than one outbreak per year.
- The absence of antiepileptic antecedent and electroencephalogram without epileptic activity.
- For females: postmenopausal or surgically sterile, or using an acceptable method of birth control
Exclusion
- History of cardiovascular disease (syncope, arrhythmia, or myocardial infarction within the last two years), systolic blood pressure greater than 150 or less than 70 mm Hg, diastolic blood pressure greater than 110 or less than 50 mm Hg, or heart rate greater than 110 or less than 50 beats/minute; impaired hepatic function (total hepatic enzyme or bilirubin levels greater than 2 times the upper limits of normal) or impaired renal function (creatinine level greater than 2 times the upper limits of normal) less than 6 months before the study
- Known allergy to pyridine-containing drugs
- Neurologic, degenerative, or psychiatric disorders that would impair the patient's ability to complete the protocol
- Any illness or abnormality that would jeopardize patient safety or interfere with the conduct of the study
- History of substance abuse
- Inability to discontinue excluded concomitant drug therapy
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02280096
Start Date
October 1 2014
End Date
February 1 2017
Last Update
September 12 2019
Active Locations (1)
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1
Hospital de Especialidades, CMN Siglo XXI
Mexico City, Mexico City, Mexico, 06725