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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002041-40-ES
Enrollment
Unknown
Registered
2005-10-03
Start date
2005-10-14
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tourette syndrome

Interventions

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 u

Sponsors

Hospital Sant Joan de Déu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: · Patients with transient tics (duration less a year) · Patients who are expected to move from Catalonia in the next two years.

Design outcomes

Primary

MeasureTime frame
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—

Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026