drugset / Trial / NCT00113815
Topiramate as Adjunctive Therapy in Infants 1-24 Months for the Control of Partial Onset Seizures
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the tolerability, safety and efficacy of topiramate in infants with refractory partial onset seizures (POS).
Timeline
- Start
- 2005-05
- Primary completion
- 2007-06
- Completion
- 2007-11
Outcome
Missed primary endpoint
paper Median percentage reduction from baseline in daily POS rate was not significantly different (p = 0.97) between topiramate 25 mg/kg (20.4%) and placebo (13.1%). PMID 20089937 ↗
Publications
- Results Novotny E, Renfroe B, Yardi N, Nordli D, Ness S, Wang S, Weber T, Kurland CL, Yuen E, Eerdekens M, Venkatraman L, Nye JS, Ford L. Randomized trial of adjunctive topiramate therapy in infants with refractory partial seizures. Neurology. 2010 Mar 2;74(9):714-20. doi: 10.1212/WNL.0b013e3181d1cd4c. Epub 2010 Jan 20.
- Ness S, Todd MJ, Wang S, Eerdekens M, Nye JS, Ford L. Adaptive behavior outcomes in infants treated with adjunctive topiramate. Pediatr Neurol. 2012 Jun;46(6):350-8. doi: 10.1016/j.pediatrneurol.2012.02.028.
- Puri V, Ness S, Sattaluri SJ, Wang S, Todd M, Yuen E, Eerdekens M, Nye JS, Manitpisitkul P, Shalayda K, Ford L. Long-term open-label study of adjunctive topiramate in infants with refractory partial-onset seizures. J Child Neurol. 2011 Oct;26(10):1271-83. doi: 10.1177/0883073811406982. Epub 2011 Jun 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Topiramate | Small molecule | 5 mg/kg | Oral |
| Subject | Topiramate | Small molecule | 15 mg/kg | Oral |
| Subject | Topiramate | Small molecule | 25 mg/kg | Oral |