drugset / Trial / NCT01921205
Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Study to evaluate the efficacy of Lacosamide (LCM) administered in addition to 1 to ≤3 other Anti-Epileptic Drugs in subjects with epilepsy ≥4 years to \<17 years of age who currently have uncontrolled partial onset seizures.
Timeline
- Start
- 2013-08-29
- Primary completion
- 2017-01-24
- Completion
- 2017-01-24
Publications
- Johnson ME, McClung C, Bozorg AM. Analyses of seizure responses supportive of a novel trial design to assess efficacy of antiepileptic drugs in infants and young children with epilepsy: Post hoc analyses of pediatric levetiracetam and lacosamide trials. Epilepsia Open. 2021 Jun;6(2):359-368. doi: 10.1002/epi4.12482. Epub 2021 May 3.
- Babar RK, Bresnahan R, Gillespie CS, Michael BD. Lacosamide add-on therapy for focal epilepsy. Cochrane Database Syst Rev. 2021 May 17;5(5):CD008841. doi: 10.1002/14651858.CD008841.pub3.
- Farkas V, Steinborn B, Flamini JR, Zhang Y, Yuen N, Borghs S, Bozorg A, Daniels T, Martin P, Carney HC, Dimova S, Scheffer IE; SP0969 Study Group. Efficacy and tolerability of adjunctive lacosamide in pediatric patients with focal seizures. Neurology. 2019 Sep 17;93(12):e1212-e1226. doi: 10.1212/WNL.0000000000008126. Epub 2019 Aug 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lacosamide | Other / unclassified | 3 mg/kg | Oral |
| Subject | Lacosamide | Other / unclassified | 4 mg/kg | Oral |
| Subject | Lacosamide | Other / unclassified | 6 mg/kg | Oral |
| Subject | Lacosamide | Other / unclassified | 150 mg | Oral |
| Subject | Lacosamide | Other / unclassified | 200 mg | Oral |