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

UCB logo

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)

255 participants in 1 patient group

Levetiracetam
Experimental group
Treatment:
Drug: levetiracetam (LEV)

Trial contacts and locations

85

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems