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 range4 Years – 17 Years

SexALL

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

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