Effect of cerebrolysin on remyelination processes in multiple sclerosis patients in stage of relapse regression

Abstract

To evaluate the efficacy and safety of Cerebrolysin (EVER Neuro Pharma GmbH, Austria) in the treatment of patients with multiple sclerosis (MS) in stage of relapse regression. The study involved 40 patients with remitting MS (McDonald criteria 2010) in stage of MS relapse regression after pulse therapy with methylprednisolone 1000 mg/day 5. Patients randomized into 2 groups: group 1 (G1, n=20) received cerebrolysin 20 ml per 200 ml of 0.9% NaCl solution 1 times per day 10; Group 2 (G2, n=20) - only 200 ml 0.9% NaCl solution on analogical scheme. All patients before and 3-4 weeks after the treatment were carried out assessment of vital signs, routine laboratory tests, tests of cognitive-motor functions (SDMT), visual acuity (LCAT), a comprehensive neurophysiological examinations (CNE). 4 patients in the G1 with presence of previously identified G+ lesions (G+L) were conducted MRI of brain after 3-4 weeks after treatment. In G1 the average age of the patients was 27.35 (5.65) years, the ratio of M/F - 40/60%, the duration of the disease 29.9 (11.01) months, the EDSS in relapse stage - 3.5 [2.0; 4.5] points. The average age of patients in G2 was 26.65 (4.93) years, the ratio of M/F - 35/65%, the duration of the disease - 30.25 (11.98) months, the EDSS in relapse stage - 3.0 [1.5; 4.5] points. Clinical relapse of MS was categorized into groups as follows: optic neuritis (15% vs. 30%; p=0.26), stem dysfunction (15% vs. 25%; p=0.43), hemispheric dysfunction (50% vs. 35%; p=0.34), transverse myelitis (20% vs. 10%; p=0.38). 17 patients (85%) in G1 and 18 patients (90%) in G2 completed a full course of treatment. In both groups showed significant regression estimation EDSS (2.0 [1.75; 2.5] vs. 2.5 [1.75; 2.5]), while significant intergroup differences were not found (p=0.665). In G1 was noted more pronounced dynamics of performance improved in testing MSFC and SDMT (p=0.038 and p=0.026, respectively). Significant intergroup differences in the dynamics of improvement VCAT values were not found (p=0.658). Also in G1 was revealed greater regression of total variance in the CNE than G2 (70.59% vs. 27.78%, p=0.028), while in almost all cases the previously identified neurophysiological abnormalities are not completely regressed. In addition to G1 was marked a tendency to reduce of progressive deterioration of CNE indicators (10% vs. 30%; p=0.228). On MRI cerebrolysin treatment was not associated with an increase of G+L (G+L number before treatment in 4 patients - 14, after treatment - 12), which indicates a potential anti-inducing effect of the drug on the intrathecal inflammation in MS. Cerebrolysin positive role in the stimulation of remyelination process in MS has been confirmed by CNE and the selected treatment regimen has demonstrated its safety. Effect of the drug appear to be due to its composition: so according to a group of authors found that investigated the drug contained fragments of tubulin, actin and myelin basic protein, all of which is necessary to ensure non-specific trophic regenerated CNS myelin sheath.