Evaluation of efficacy, safety and tolerability of an ADd-on therapy with Cianocabalamine Vitamin B12 plus Calcium levofolinate in relapsing-remitting multiple sclerosis patients Already in treatment with Nterferon beta over a period of 24 months for a better lonterm outComE - ADVANCE

Overview

No summary available.

Registry

who.int

Start Date

May 9, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Patients with RRMS according McDonald Criteria23 2\. EDSS score between 0\.0 and 5\.5 3\. Currently and for the first time treated with, and tolerating, Interferon beta subcutaneously, and having received this treatment for more than 3 but not more than 6 months. 4\. Age between 18 and 50 years, included
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•2\. Primary or secondary progressive MS 3\. Pregnancy, a positive serum pregnancy test beta HCG at screen visit, a positive urine pregnancy test at baseline visit, or breast feeding 4\. Uncontrolled, clinically significant heart diseases, such as dysrhythmias, angina, or uncompensated congestive heart failure 5\. Uncontrolled Seizure disorder 6\. Infections or any internal medical conditions that could threaten the general health of the patient in the short term. 7\. Gastroresection 8\. Prior diagnosis of neoplasia or mieloproliferative diseases. 9\. Medical or psychiatric conditions that compromise the patient s ability to give informed consent