Efficacy and Safety of Levetiracetam in Partial Seizures Control, With or Without Secondary Gener… (NCT01392768) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Levetiracetam in Partial Seizures Control, With or Without Secondary Generalization
126 participantsStarted 2013-01
Plain-language summary
The purpose of this study is to determine whether levetiracetam as adjunctive therapy is effective in the treatment of partial seizures, with or without secondary generalization, associated with refractory focal epilepsy.
Who can participate
Age range4 Years – 65 Years
SexALL
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Inclusion Criteria:
* Patients of both sexes, aged between 04 and 65 years, remaining the feasibility of a legal guardian in accordance with need, able to understand and provide written informed consent and able to allow compliance at the treatment and the requirements of the protocol;
* Patient´s weight ≥ 20kg;
* Consistent diagnosis of refractory focal epilepsy, with or without secondary generalization;
* Patient with onset of seizures for at least 02 years preceding the screening visit;
* Presence at least 12 partial seizures during the 03 months preceding the screening visit (04 seizures per month);
* Only seizures that generate motor manifestation will be recorded in this study.
* Absence of brain injury progressive or expansive, previously documented by CT scan, MRI or other imaging test applicable (in the last 05 years;
* Patient with electroencephalogram performed up to 02 years before this visit;
* Subject with stable regimen (minimum of 01 month) from one to three antiepileptic drugs.
* Vagus nerve stimulation for 04 weeks prior to V1, or use of benzodiazepines for more than 07 consecutive days will be considered as concomitant epileptic drugs)
Exclusion Criteria:
* Patients with:
* Seizures of non epileptic origin;
* Pseudoseizures;
* Seizures occurring in clustered patterns (03 or more seizures in 30 minutes), in the 03 months preceding the screening visit (V1);
* History of status epilepticus while taking antiepileptic drugs during the 03 months…