Long-term Extension Study to Investigate Lacosamide as an Add-on Therapy in Children With Partial Onset Seizures
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 500
Summary
- Conditions
- Epilepsy
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 117 years
- Gender
- Both males and females
Description
The primary objective of this study is to evaluate the long-term safety and tolerability of LCM administered concomitantly with 1 to ≤3 Anti-Epileptic Drugs (AEDs) in subjects with epilepsy ≥1 month to ≤18 years of age who currently have uncontrolled partial onset seizures. The secondary objective i...
The primary objective of this study is to evaluate the long-term safety and tolerability of LCM administered concomitantly with 1 to ≤3 Anti-Epileptic Drugs (AEDs) in subjects with epilepsy ≥1 month to ≤18 years of age who currently have uncontrolled partial onset seizures. The secondary objective is to evaluate the efficacy during long-term exposure to LCM in subjects epilepsy ≥1 month to ≤18 years of age. An additional objective is to assess behavior, cognition, quality of life, and development during long-term LCM exposure in pediatric subjects
Tracking Information
- NCT #
- NCT01964560
- Collaborators
- PRA Health Sciences
- Investigators
- Study Director: UCB Cares +1 844 599 2273
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