Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy
Summary
The purpose is to assess the safety of lacosamide in subjects with uncontrolled primary generalized tonic-clonic (PGTC) seizures with idiopathic generalized epilepsy.
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Epilepsy
Intervention
Lacosamide
Location
Little Rock
Arkansas
United States
Status
Recruiting
Source
UCB, Inc.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01118949
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Myoclonic Epilepsy, Juvenile
A disorder characterized by the onset of myoclonus in adolescence, a marked increase in the incidence of absence seizures (see EPILEPSY, ABSENCE), and generalized major motor seizures (see EPILEPSY, TONIC-CLONIC). The myoclonic episodes tend to occur shortly after awakening. Seizures tend to be aggravated by sleep deprivation and alcohol consumption. Hereditary and sporadic forms have been identified. (From Adams et al., Principles of Neurology, 6th ed, p323)
Epilepsy
A disorder characterized by recurrent episodes of paroxysmal brain dysfunction due to a sudden, disorderly, and excessive neuronal discharge. Epilepsy classification systems are generally based upon: (1) clinical features of the seizure episodes (e.g., motor seizure), (2) etiology (e.g., post-traumatic), (3) anatomic site of seizure origin (e.g., frontal lobe seizure), (4) tendency to spread to other structures in the brain, and (5) temporal patterns (e.g., nocturnal epilepsy). (From Adams et al., Principles of Neurology, 6th ed, p313)
Mephenytoin
An anticonvulsant effective in tonic-clonic epilepsy (EPILEPSY, TONIC-CLONIC). It may cause blood dyscrasias.
Epilepsy, Rolandic
An autosomal dominant inherited partial epilepsy syndrome with onset between age 3 and 13 years. Seizures are characterized by PARESTHESIA and tonic or clonic activity of the lower face associated with drooling and dysarthria. In most cases, affected children are neurologically and developmentally normal. (From Epilepsia 1998 39;Suppl 4:S32-S41)
Epilepsy, Reflex
A subtype of epilepsy characterized by seizures that are consistently provoked by a certain specific stimulus. Auditory, visual, and somatosensory stimuli as well as the acts of writing, reading, eating, and decision making are examples of events or activities that may induce seizure activity in affected individuals. (From Neurol Clin 1994 Feb;12(1):57-8)
Clinical Trials
Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures
Lacosamide (LCM) is an investigational drug that is being studied as a treatment in male and female patients with partial seizures in the indication Epilepsy. The main purpose of this tri...
The purpose is to obtain data on the safety and seizure frequency associated with long-term oral lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects wi...
Trial To Study The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures
The purpose of this trial is to evaluate the safety and pharmacokinetics of Lacosamide (LCM) syrup in children ages 2-17 with uncontrolled partial seizures when added to 1 to 3 other seizu...
The objective of this historical-controlled trial is to demonstrate the efficacy and safety of conversion to lacosamide monotherapy in subjects with partial-onset seizures who are withdra...
Safety of Conversion to Lacosamide Monotherapy for Partial-Onset Seizures Patients
The purpose of this study is to see if Lacosamide is safe and effective, when taken alone, to decrease the number and severity of seizures in patients 16 to 70 years of age who are withdra...
PubMed Articles
Lacosamide (LCM) is an antiepileptic drug (AED) that has demonstrated a good efficacy in controlling seizures as an add-on in adult epilepsy. To date, there have been no studies on LCM in patients wit...
The Use of Lacosamide in Refractory Status Epilepticus.
BACKGROUND: Case reports suggest lacosamide may have a role in status epilepticus (SE). The purpose of this case series is to describe the use of lacosamide in refractory SE (RSE) at our institution....
Abstract Objective: This article provides a short but comprehensive pharmacotherapeutic update of adjunctive therapy with lacosamide for partial-onset seizures in adult patients. Research design and m...
Therapeutic drug monitoring of lacosamide.
Lacosamide is a third generation antiepileptic drug, available in France since 2008. It is indicated in combination therapy for the treatment of inadequately controlled focal seizures, from the age of...
BACKGROUND: Lacosamide is a novel anti-epileptic drug that enhances the slow- and not fast-inactivating state of voltage-gated sodium channels. Lacosamide has demonstrated analgesic efficacy in severa...
