A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy
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|ClinicalTrials.gov Identifier: NCT00150709|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : February 15, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Epilepsy, Partial||Drug: Levetiracetam (Keppra)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||238 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of The Safety And Efficacy Of Levetiracetam (Ucb L059) In Children With Epilepsy|
|Study Start Date :||February 1998|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||January 2006|
- To allow pediatric patients who have participated in a previous trials the opportunity to receive open-label levetiracetam (Keppra) treatment.
- Efficacy measured by weekly seizure frequency.
- To obtain standardized descriptive safety and efficacy data in pediatric epileptic patients
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|Ages Eligible for Study:||up to 16 Years (Child)|
|Sexes Eligible for Study:||All|
- Have completed Study N151, or any other applicable pediatric trials of Levetiracetam (Keppra®)
- Be a patient for whom the treatment of Levetiracetam (Keppra®) would be of potential benefit such that the patient/parent(s)/legal guardian and the Investigator agree to continue treatment.
- Not be on a ketogenic diet (during the course of this study).
- Not have seizures too close together to accurately count (i.e., the patient's seizures must be countable).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150709
|Study Director:||UCB Clinical Trial Call Center||UCB Pharma|
|Other Study ID Numbers:||
|First Posted:||September 8, 2005 Key Record Dates|
|Last Update Posted:||February 15, 2017|
|Last Verified:||February 2017|
Epilepsy, Pediatric , partial onset epilepsy,
Central Nervous System Diseases
Nervous System Diseases