Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures

Completed · Phase 3

Conditions studied: Epilepsy, Partial

In brief

To allow pediatric patients with partial onset seizures an opportunity to receive (as follow-up to studies N01009(NCT00105040)/N01103(NCT00175890) or by direct enrollment) open-label levetiracetam treatment, continue studying cognition and behavior in children, and continue collection of safety/efficacy data.

Key facts

Study ID

NCT00152516

Run by

UCB Pharma

People needed

255

Starts

2004-10-01

Expected to finish

2008-06-01

Last updated by the study team

2013-02-12

Who can join

Age: 0 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pediatric patients with partial onset seizures, with 1 to 2 anti-epileptic drugs (AEDS), with participation in previous levetiracetam pediatric studies (N01009 or N01103) or direct enrollment, for whom levetiracetam treatment will be of possible benefit

You may not qualify if…

• Patients on a ketogenic diet
• Seizures too close together to accurately count
• Pseudoseizures
• Status epilepticus 1 month prior Visit 1
• Current diagnosis of Lennox-Gastaut Syndrome or epilepsy secondary to a progressing cerebral disease will be excluded from the study.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Denver, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Bradenton, Florida, United States
• Study site — Loxahatchee Groves, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Tallahassee, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Saint Paul, Minnesota, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Edison, New Jersey, United States
• Study site — Voorhees Township, New Jersey, United States
• Study site — Buffalo, New York, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Syracuse, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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