Evaluating the short-term effect of Fampridine on cognitive function in Multiple sclerosis patients
Phase 3
Recruiting
- Conditions
- Multiple sclerosis.Multiple sclerosis
- Registration Number
- IRCT20161212031362N4
- Lead Sponsor
- Iranian Center of Neurological Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 108
Inclusion Criteria
Definite MS diagnosis according to McDonald 2017 criteria
Age between 18-60 years
SDMT score below the 20th percentile of normative values
Exclusion Criteria
History of relapse within 2 months
History of seizure/epilepsy
History of major depression or psychosis
Reluctance to enroll in the study
Moderate or higher renal dysfunction (eGFR=< 50mL/min/1.73m2)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in (SDMT) Symbol Digit Modalities Test score (improvement of equal or greater than 4 points or more than 20% increase compared to baseline score is considered a meaningful change). Timepoint: First visit (baseline) and 12 weeks after intervention. Method of measurement: SDMT test which is scored based on the number of correct answers in 90 seconds.
- Secondary Outcome Measures
Name Time Method