Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures
(VALUE Trial)
Trial Summary
What is the purpose of this trial?
This trial tests the safety and effectiveness of an oral medication called lacosamide for patients aged 4 and older who have epilepsy with uncontrolled seizures. Lacosamide helps stabilize brain activity to reduce seizures.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop your current medications, but you cannot be on any investigational drugs or using experimental devices besides lacosamide.
What data supports the effectiveness of the drug Lacosamide?
Lacosamide is effective in controlling seizures in patients with epilepsy, as shown in clinical trials where it significantly reduced seizure rates when used alongside other antiepileptic drugs. It is generally well tolerated and can be used as both oral and intravenous therapy, providing flexibility in treatment options.12345
How does this drug differ from other treatments for pain?
Research Team
UCB Cares
Principal Investigator
001 844 599 2273
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral lacosamide as adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may continue to receive lacosamide to evaluate long-term safety and efficacy
Treatment Details
Interventions
- Lacosamide
Find a Clinic Near You
Who Is Running the Clinical Trial?
UCB BIOSCIENCES, Inc.
Lead Sponsor