MedPath

Double-blind, placebo controlled cross-over study to assess the efficacy of Levetiracetam in paediatric and childhood non-epileptic myoclonusEstudio 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

Active, not recruiting
Conditions
on-epileptic myoclonus
Registration Number
EUCTR2005-002042-19-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

·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

·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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath