CompletedPhase 2

A Safety and Efficacy Follow-up Study With Levetiracetam in Children (4-17 Years Old) Suffering From Absence Seizures

4 participantsStarted 2000-05

Plain-language summary

This long-term open label follow-up trial gave pediatric subjects suffering from typical absences in CAE or JAE the opportunity to continue levetiracetam treatment after participation in the pilot study (study N162) or the double-blind study (study N163). Safety and efficacy data were obtained.

Who can participate

Age range

4 Years – 17 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: * Male/female 4-17 years old having participated in study N162 or in study N163 * suffering from typical absences with 3 Hz spike-wave discharges, with or without tonic-clonic seizures, in CAE or JAE * expected reasonable benefit (efficacy and tolerability) of levetiracetam long term administration Exclusion Criteria: * allergy/intolerance to pyrrolidine derivatives and/or excipients * use of \> 2 concomitant antiepileptic treatment or valproate, ethosuximide or lamotrigine

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.

What they're measuring

Continue levetiracetam treatment after participation in the pilot-study N162 or in study N163; Assess long-term safety profile and efficacy of levetiracetam

Trial details

NCT IDNCT00545012

SponsorUCB Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2003-05

View on ClinicalTrials.gov More Absence Seizures trials

Who can participate

Age range

4 Years – 17 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.