drugset / Trial / NCT01146951
A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To confirm that the combination therapy of rufinamide has superior efficacy compared to placebo in patients with Lennox-Gastaut syndrome.
Timeline
- Start
- 2010-06
- Primary completion
- 2011-08
- Completion
- 2011-08
Outcome
Met primary endpoint
registry analysis (superiority or other test); Rufinamide (E2080) vs Placebo; p = 0.003; Hodges-Lehmann -26.65 (90% CI -40.30 to -11.80); Wilcoxon (Mann-Whitney) NCT01146951 ↗
Publications
- Brigo F, Jones K, Eltze C, Matricardi S. Anti-seizure medications for Lennox-Gastaut syndrome. Cochrane Database Syst Rev. 2021 Apr 7;4(4):CD003277. doi: 10.1002/14651858.CD003277.pub4.
- Panebianco M, Prabhakar H, Marson AG. Rufinamide add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2020 Nov 8;11(11):CD011772. doi: 10.1002/14651858.CD011772.pub3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rufinamide | Small molecule | 1000 mg | Oral |
| Subject | Rufinamide | Small molecule | 1800 mg | Oral |
| Subject | Rufinamide | Small molecule | 2400 mg | Oral |
| Subject | Rufinamide | Small molecule | 3200 mg | Oral |