drugset / Trial / NCT01465997
Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
Non-randomizedParallel-groupTriple-blindTreatment
Summary
Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with primary safety variables including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs, reporting of Serious AEs (SAEs).
Timeline
- Start
- 2012-05
- Primary completion
- 2017-01
- Completion
- 2017-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carbamazepine | Small molecule | 200 mg | — |
| Comparator | Carbamazepine | Small molecule | 400 mg | — |
| Comparator | Carbamazepine | Small molecule | 600 mg | — |
| Comparator | Carbamazepine | Small molecule | 800 mg | — |
| Comparator | Carbamazepine | Small molecule | 1000 mg | — |
| Comparator | Carbamazepine | Small molecule | 1200 mg | — |
| Subject | Lacosamide | Other / unclassified | 100 mg | — |
| Subject | Lacosamide | Other / unclassified | 200 mg | — |
| Subject | Lacosamide | Other / unclassified | 300 mg | — |
| Subject | Lacosamide | Other / unclassified | 400 mg | — |
| Subject | Lacosamide | Other / unclassified | 500 mg | — |
| Subject | Lacosamide | Other / unclassified | 600 mg | — |