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Double-blind, placebo controlled cross-over study to assess the efficacy of Levetiracetam in paediatric and childhood non-epileptic myoclonus Estudio cruzado, aleatorizado, doble ciego controlado con placebo, para evaluar la eficacia del Levetiracetam en el tratamiento del mioclonus no epiléctico en pacientes pediátricos y adolescentes

Double-blind, placebo controlled cross-over study to assess the efficacy of Levetiracetam in paediatric and childhood non-epileptic myoclonus Estudio cruzado, aleatorizado, doble ciego controlado con placebo, para evaluar la eficacia del Levetiracetam en el tratamiento del mioclonus no epiléctico en pacientes pediátricos y adolescentes

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002042-19-ES
Enrollment
Unknown
Registered
2005-09-30
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

Non-epileptic myoclonus

Interventions

Trade Name: Keppra 250 mg Product Name: Levetiracetam Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Levetiracetam CAS Number: 102767 28 2 Concentration unit: mg milligram(s) Concentrat

Sponsors

Hospital Sant Joan de Déu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: · Aged between 6 and 18 years. · Myoclonus is the sole or primary neurological abnormality. · Confirmed diagnosis (by EEG or EMG) of primary non-epileptic myoclonus ( myoclonus-dystonia, essential myoclonus, hyperekplexia, etc.) or secondary non-epileptic myoclonus. · 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 any of the conditions above mentioned but with a transient (duration less a year) occurrence. · Patients who are expected to move from Catalonia in the next two years. · Patients with dyskinetic cerebral palsy

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the efficacy of Levetiracetam in the treatment of non-epileptic myoclonus in patients between 6 and 18 years old. ;Secondary Objective: To evaluate the safety of Levetiracetam in patients between 6 and 18 years old with non-epileptic myoclonus. To evaluate the quality of life of patients between 6 and 18 years old with non-epileptic myoclonus in treatment with Levetiracetam. ;Primary end point(s): Control of myoclonic spasms in patients between 6 and 18 years old with non-epileptic myoclonus—

Countries

Spain

Outcome results

None listed

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