NCT02408549

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

An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: UCB BIOSCIENCES, Inc. · Industry
• Sex: All
• Age: 4 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	Lacosamide Tablet	* Active substance: Lacosamide * Pharmaceutical form: Tablet * Concentration: 50 mg and 100 mg * Route of Administration: Oral administration
DRUG	Lacosamide Oral Solution	* Active substance: Lacosamide * Pharmaceutical form: Oral solution * Concentration: 10 mg/ml * Route of Administration: Oral administration

Timeline

• Start date: 2015-08-03
• Primary completion: 2023-03-30
• Completion: 2023-03-30
• First posted: 2015-04-03
• Last updated: 2023-12-14
• Results posted: 2023-12-14

Locations

87 sites across 21 countries: United States, Australia, Brazil, Bulgaria, China, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Poland, Portugal, Romania, Russia, Slovakia, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study