Evaluation of efficacy, safety and tolerability of an ADd-on therapy w
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
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- CALCIO FOLINATO DC.IT
- Levoleucovorin
Unknown
What it measured
Main measures
Efficacy of the association Cianocobalamine plus Calcium levofolinate and INFBvs. Placebo1 plus Placebo2 and INFBin patients with Relapsing-Remitting Multiple Sclerosis, evaluated by the increase of brain atrophy, measured as rate of volumetric changes of the whole-brain parenchyma on MRI scans after a treatment period of 24 months.
MRI lesionsBrain volume loss
Who could take part
Relapsing MS · EDSS 0.0 to 5.5
Show the full criteria
Inclusion criteria
Inclusion: 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 Exclusion: 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
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Efficacy of the association Cianocobalamine plus Calcium levofolinate and INFBvs. Placebo1 plus Placebo2 and INFBin patients with Relapsing-Remitting Multiple Sclerosis, evaluated by the increase of brain atrophy, measured as rate of volumetric changes of the whole-brain parenchyma on MRI scans after a treatment period of 24 months.
Papers
Loading reviews and guidelines…
History
Started
May 2006