Amantadine and dalfampiridine effects on multiple sclerosis
Phase 2
Recruiting
- Conditions
- Multiple sclerosis.Multiple sclerosis
- Registration Number
- IRCT20190804044429N2
- Lead Sponsor
- Mazandaran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Adult patients were aged more than 18 years
Patients with multiple sclerosis according to Mcdonald criteria 2017 and EDSS less than 5.5
MS patients with at least fatigue score of 33 according to MFIS
Exclusion Criteria
Severe depression
Hypothyroidism
Severe anemia ( Hb‹ 9 g/dl)
Pregnancy or breast feeding
Ischemic heart disease or cardiovascular disease
Renal insufficiency
MS exacerbation within 30 days before
Uncontrolled blood pressure (BP more than 160/100 mm Hg)
use of other effective treatment on fatigue
Alcohol, recreational and substance abuse history
Monoamine oxidase inhibitors (MAOIs) use
Narcolepsy history
Psychosis history
Seizure history
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fatigue improvement. Timepoint: At weeks 4, and 8. Method of measurement: MFIS questionnaire.
- Secondary Outcome Measures
Name Time Method Quality of life. Timepoint: At weeks 4 , 8. Method of measurement: SF-36 Questionnaire.;Tolerable of therapeutic regimen. Timepoint: Weekly. Method of measurement: History taking.