Efficacy and activity of levetiracetam on Multiple Sclerosis cerebellar symptoms: a multicenters double blind, randomized, placebo-controlled, cross over study

INTERVENTION: Trade Name: KEPPRA Pharmaceutical Form: Coated tablet INN or Proposed INN: Levetiracetam Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ CONDITION: Patients with an established and stable Multiple Sclerosis (according to Poser criteria). ; MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis PRIMARY OUTCOME: Main Objective: The primary objective of this study is to evaluate the efficacy of Levetiracetam on cerebellar symptoms (through the 9 hole‐peg test) in patients affected by Multiple Sclerosis. Primary end point(s): Variation to nine‐hole peg test Secondary Objective: 1)evaluation of the efficacy of Levetiracetam on cerebellar symptoms through the Tremor severity scale 2) evaluation of the efficacy of Levetiracetam on cerebellar symptoms through the Ataxia scale 3) evaluation of the efficacy of Levetiracetam on cerebellar symptoms through the Tremor activity of daily living scale 4) evaluation of the efficacy of Levetiracetam on cerebellar symptoms through the Tremor‐related handicap questionnaire 5) evaluation of the efficacy of Levetiracetam on cerebellar symptoms through VAS and CGI scales. 6) evaluation of the activity of Levetiracetam on cerebellar symptoms through a kinematic analisys. INCLUSION CRITERIA: 1) male and female aged ≥ 18 years old < 65 years old; 2) Diagnosis of stable multiple sclerosis (according to Poser criteria), without relapses or a worsening major than 1 point at the EDSS (Expanded Disability Status Scale) in the last 3 months before 3) EDSS < than 7.5 at inclusion 4) Presence of kinetic‐intention tremor (tremor will be assessed in 3 states of the arm: rest, posture, movement during a finger‐noise‐finger test) 5) SCRIPPS scale for sensory and motor system ≥ than 3 6) Ashworth scale < than 2 7) written informed consent 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