Cinnovex versus Avonex clinica Trial
Phase 3
- Conditions
- Multiple Sclerosis.Multiple Sclerosis
- Registration Number
- IRCT138711281696N1
- Lead Sponsor
- Cinnagen Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
RRMS as defined by Mc Donald's criteria, Age: 18-50 years, EDSS 0-5.5, signing informed consent
Exclusion Criteria
Pregnancy or the desire to become pregnant during the trial period, major depression or psychiatric problem, history of suicidal attempt, Allergy to INF-beta, IVIG during the past 6 months, Cytotoxic medications, increased liver enzymes >3 times, leucopenia, missing patient for 4 consecutive weeks, plasmapheresis.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disability. Timepoint: Monthly for 2 years, since one month after intervention. Method of measurement: Expanded disability status scale (EDSS).
- Secondary Outcome Measures
Name Time Method umber of attacks. Timepoint: monthly for 2 years, since one month after intervention. Method of measurement: reported by the patient and detected on examination.;MRI Changes. Timepoint: Baseline and since 6 months after intervention, every 6 months for 2 years. Method of measurement: Image J software.;Neutralizing Antibodies. Timepoint: every 6 months for 2 years, since 6 months after intervention,. Method of measurement: CPE method.;Adverse events. Timepoint: monthly afterwards for 2 years, scince one week after intervention weekly for the first month. Method of measurement: checklist.