drugset
drugset / Trial / NCT02408549

Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures

NCT02408549 ↗

Phase 3 Completed 239 enrolled UCB BIOSCIENCES, Inc.
NaSingle-groupOpen-labelTreatment

Summary

Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures (PGTCS) in subjects \>= 4 years of age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM SP0982 \[NCT02408523\] study.

Timeline

Start
2015-08-03
Primary completion
2023-03-30
Completion
2023-03-30

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Lacosamide Other / unclassified 2 mg/kg Oral
Subject Lacosamide Other / unclassified 4 mg/kg Oral
Subject Lacosamide Other / unclassified 8 mg/kg Oral
Subject Lacosamide Other / unclassified 10 mg/kg Oral
Subject Lacosamide Other / unclassified 12 mg/kg Oral
Subject Lacosamide Other / unclassified 100 mg Oral
Subject Lacosamide Other / unclassified 200 mg Oral
Subject Lacosamide Other / unclassified 400 mg Oral
Subject Lacosamide Other / unclassified 600 mg Oral
Subject Lacosamide Other / unclassified 800 mg Oral

Indications

epilepsy