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 range
4 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.