BACKGROUND AND PURPOSE: The aim of this study was to evaluate the activity measured by kinematic analysis, tolerability and efficacy of levetiracetam (LEV) in multiple sclerosis (MS) patients affected by cerebellar symptoms, in a randomized single-blind, placebo-controlled cross-over study. METHODS:Eight MS subjects with cerebellar signs (five female and three male; mean EDSS: 4.77; mean disease duration 9.2) performed a reaching task on a digitizing tablet and their trajectories went through a kinematic analysis. The subjects were assessed at baseline, after 21 days of treatment, after wash-out period (day 35) and after 21 days of treatment (day 56). LEV was used at the maximum dosage of 1500 mg daily. The primary outcome was the modification on smoothness (JERK) whilst aiming error (AAI) and centripetal acceleration (CA) were considered as secondary outcomes. RESULTS: Two subjects were excluded from the final analysis. Primary outcome (i.e. JERK) was significantly affected by the administration of LEV overtime (nine arms in active treatment versus three arms in placebo decreased the mean values of their JERK). Regarding secondary outcomes CA was significantly affected by the administration of LEV. No statistical significant results were found comparing clinical scales during the four assessments. DISCUSSION: The results indicate that LEV was able to modify kinematic parameter so the medication was active but no improvement in clinical scales was observed. LEV needs to be tested in a larger group of subjects designed to verify treatment efficacy using higher dosage of the medication.
RCT Entities:
BACKGROUND AND PURPOSE: The aim of this study was to evaluate the activity measured by kinematic analysis, tolerability and efficacy of levetiracetam (LEV) in multiple sclerosis (MS) patients affected by cerebellar symptoms, in a randomized single-blind, placebo-controlled cross-over study. METHODS: Eight MS subjects with cerebellar signs (five female and three male; mean EDSS: 4.77; mean disease duration 9.2) performed a reaching task on a digitizing tablet and their trajectories went through a kinematic analysis. The subjects were assessed at baseline, after 21 days of treatment, after wash-out period (day 35) and after 21 days of treatment (day 56). LEV was used at the maximum dosage of 1500 mg daily. The primary outcome was the modification on smoothness (JERK) whilst aiming error (AAI) and centripetal acceleration (CA) were considered as secondary outcomes. RESULTS: Two subjects were excluded from the final analysis. Primary outcome (i.e. JERK) was significantly affected by the administration of LEV overtime (nine arms in active treatment versus three arms in placebo decreased the mean values of their JERK). Regarding secondary outcomes CA was significantly affected by the administration of LEV. No statistical significant results were found comparing clinical scales during the four assessments. DISCUSSION: The results indicate that LEV was able to modify kinematic parameter so the medication was active but no improvement in clinical scales was observed. LEV needs to be tested in a larger group of subjects designed to verify treatment efficacy using higher dosage of the medication.