Double-blind, placebo controlled cross-over study to assess efficacy of Levetiracetam in paediatric and childhood Tourette syndrome. Estudio cruzado, aleatorizado, doble ciego controlado con placebo, para evaluar la eficacia del Levetiracetam en el control de los tics de pacientes pediátricos y adolescentes con síndrome de Gilles de la Tourette

INTERVENTION: Trade Name: Keppra 250 mg Product Name: Levetiracetam Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: levetiracetam CAS Number: 102767 28 2 Current Sponsor code: ucb‐L059 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Trade Name: Keppra 500 mg Product Name: Levetiracetam Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: levetiracetam CAS Number: 102767 28 2 Current Sponsor code: ucb‐L059 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Tourette syndrome PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of Levetiracetam in patients between 6 and 18 years old with Tourette syndrome Primary end point(s): Control of motor and phonic tics in patients between 6 and 18 years old with Tourette syndrome Secondary Objective: To evaluate the safety of Levetiracetam in patients between 6 and 18 years old with Tourette syndrome INCLUSION CRITERIA: · Tics is the sole or primary neurological abnormality. · Aged between 6 and 18 years. · Confirmed diagnosis of Tourette syndrome using DSM IV criteria. · Duration of the disorder of more than 1 year. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range