drugset / Trial / NCT01463306
A 12-Month Study To Evaluate The Safety And Tolerability Of Pregabalin As Add-On Therapy In Pediatric Subjects 1 Month To 16 Years Of Age With Partial Onset Seizures And Pediatric And Adult Subjects 5 To 65 Years Of Age With Primary Generalized Tonic-Clonic Seizures
NaOpen-labelTreatment
Summary
Study A0081106 is a 12-month open-label study to evaluate the long term safety and tolerability of pregabalin as add-on therapy in pediatric subjects 1 month to 16 years of age with partial onset seizures and pediatric and adult subjects 5 to 65 years of age with primary generalized tonic-clonic seizures. Pregabalin will be administered in equally divided daily doses for 1 year, in either capsule or liquid oral formulation.
Timeline
- Start
- 2012-02-21
- Primary completion
- 2019-08-22
- Completion
- 2019-08-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pregabalin | Small molecule | 2.5 mg/kg | Oral |
| Subject | Pregabalin | Small molecule | 10 mg/kg | Oral |
| Subject | Pregabalin | Small molecule | 150 mg | Oral |
| Subject | Pregabalin | Small molecule | 600 mg | Oral |