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
- Conditions
- Tourette syndrome
- Registration Number
- EUCTR2005-002041-40-ES
- Lead Sponsor
- Hospital Sant Joan de Déu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
Exclusion Criteria
·Patients with transient tics (duration less a year)
·Patients who are expected to move from Catalonia in the next two years.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of Levetiracetam 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;Primary end point(s): Control of motor and phonic tics in patients between 6 and 18 years old with Tourette syndrome
- Secondary Outcome Measures
Name Time Method