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Pregabalin for Partial-Onset Seizures in children 1 mo-<4 years

Safety and efficacy of pregabalin in children 1 mo-<4 years with partial onset seizures

Description:

Epilepsy is often controlled by current medications. For some children, however, these medicines do not fully control their seizures. Or, these medicines may cause side effects. In this study we want to find out if a medicine (pregabalin) helps reduce partial onset seizures in children. If your child already takes antiepileptic drugs but still has seizures, we will give pregabalin as an add-on medication. Some children may receive a pill without an active drug (a placebo). We can then determine if adding pregabalin reduced seizures.

Who May Qualify?:

Full Study Description and Eligibility

  • Pediatric patients 1 mo - <4 years with partial onset seizures whose partial onset seizures are not controlled by current medication
  • Patients with 3 partial onset seizures in the month before screening for the study
Who Does Not Qualify:
  • Patients  with other seizure types or medical conditions
  • Patients under 1 month or over 4 years
Study Status:
Closed
Full IRB Study Title:
A double blind, placebo-controlled parallel-group, multicenter study of the efficacy and safety of pregabalin as adjunctive therapy in children 1 month through <4 years of age with partial onset seizures
IRB Study ID:
A0081042
If you are interested in this study or have questions about your child's eligibility, please contact:

Rebecca D. Considine Research Institute, 330-543-5012

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