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

UCB

Status and phase: Completed; Phase 3

Conditions: Epilepsy, Partial

Treatments: Drug: levetiracetam (LEV)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00152516

N01148

EudraCT number:2004-000200-40

Details and patient eligibility

About

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.

Enrollment: 255 patients

Sex: All

Ages: 1 month to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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255 participants in 1 patient group

Levetiracetam

Experimental group

Treatment:

Drug: levetiracetam (LEV)