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

AZIENDA OSPEDALIERA SAN CAMILLO FORLANINI0 个研究点目标入组 276 人开始时间: 2006年5月9日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

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