The Effect of Levetiracetam on Improving Cognitive Impairment in Relapsing-Remitting Multiple Sclerosis Patients: A Pilot Double-Blind Randomized Placebo-Controlled Clinical Trial

Background: Cognitive impairment has been identified in all stages and affects all subtypes of multiple sclerosis (MS) (40 - 65% of people with clinically definite MS). A defined therapeutic strategy has not yet been determined. Objectives: This study aimed to assess the efficacy of levetiracetam (LEV) to improve cognitive impairments in patients with relapsing-remitting MS (RRMS). Methods: A Pilot randomized; double-blinded, placebo-controlled clinical trial was conducted. The patients with a definite diagnosis of RRMS treated with first-line drugs. They were assigned into two groups; LEV and the placebo for four months. The primary outcome was the changes in cognitive domains based on the minimal assessment of cognitive function in multiple sclerosis (MACFIMS) compared to baseline. The MACFIMS was accomplished by seven tests: California verbal learning test-II (CVLT-II), paced auditory serial addition test (PASAT), symbol digit modalities testing (SDMT), brief visuospatial memory test-revised (BVMT-R), delis-Kaplan executive function system (D-KEFS), controlled oral word association test (COWAT), and judgment of line orientation (JLO). Results: A total of 32 patients entered the study and 28 patients completed the trial. The change in JLO score in the LEV group was significantly greater than in the placebo group (P-value = 0.03). After intervention in the LEV group, the SDMT and JLO scores were significantly higher than the baseline scores. Conclusions: This is the study to evaluate the effects of LEV on cognitive disorders in patients with MS. Levetiracetam was significantly effective in improving the JLO and SDMT scores in patients with RRMS compared to the placebo group.