BIOMAT Database Logo BIOMAT Database Logo

Lacosamide as adjunctive therapy for partial-onset seizures: a randomized controlled trial. 2010

Steve Chung, and Michael R Sperling, and Victor Biton, and Gregory Krauss, and David Hebert, and G David Rudd, and Pamela Doty, and
Barrow Neurological Institute, Phoenix, Arizona 85013, USA. steve.chung@chw.edu

OBJECTIVE To evaluate the efficacy and safety of lacosamide (400 and 600 mg/day) as adjunctive treatment in patients with uncontrolled partial-onset seizures taking one to three concomitant antiepileptic drugs (AEDs). METHODS This multicenter, double-blind, placebo-controlled trial randomized patients 1:2:1 to placebo, lacosamide 400 mg, or lacosamide 600 mg/day. After an 8-week baseline period, patients began treatment with placebo or lacosamide 100 mg/day, were force-titrated weekly (100 mg/day increments) to the target dose, and entered a 12-week maintenance period. RESULTS A total of 405 patients were randomized and received trial medication. Most (82.1%) were taking two to three concomitant AEDs. Median percent reductions in seizure frequency per 28 days from baseline to maintenance (intention-to-treat, ITT) were 37.3% for lacosamide 400 mg/day (p = 0.008) and 37.8% for lacosamide 600 mg/day (p = 0.006) compared to 20.8% for placebo, with responder rates of 38.3% and 41.2%, respectively, compared to placebo (18.3%, p < 0.001; ITT). Patients randomized to lacosamide showed large reductions in secondarily generalized tonic-clonic seizures, with median percent reductions in seizure frequency of 59.4% for lacosamide 400 mg/day and 93.0% for lacosamide 600 mg/day compared to 14.3% for placebo, and responder rates of 56.0% and 70.2% compared to placebo (33.3%). Dose-related adverse events included dizziness, nausea, and vomiting. CONCLUSIONS Adjunctive treatment with lacosamide 400 and 600 mg/day reduced seizure frequency for patients with uncontrolled partial-onset seizures. Lacosamide 400 mg/day provided a good balance of efficacy and tolerability; lacosamide 600 mg/day may provide additional benefit for some patients as suggested by secondary efficacy analyses, including response in patients with secondarily generalized tonic-clonic seizures.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D004244 Dizziness An imprecise term which may refer to a sense of spatial disorientation, motion of the environment, or lightheadedness. Lightheadedness,Orthostasis,Dizzyness,Light-Headedness,Light Headedness
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004359 Drug Therapy, Combination Therapy with two or more separate preparations given for a combined effect. Combination Chemotherapy,Polychemotherapy,Chemotherapy, Combination,Combination Drug Therapy,Drug Polytherapy,Therapy, Combination Drug,Chemotherapies, Combination,Combination Chemotherapies,Combination Drug Therapies,Drug Polytherapies,Drug Therapies, Combination,Polychemotherapies,Polytherapies, Drug,Polytherapy, Drug,Therapies, Combination Drug
D004828 Epilepsies, Partial Conditions characterized by recurrent paroxysmal neuronal discharges which arise from a focal region of the brain. Partial seizures are divided into simple and complex, depending on whether consciousness is unaltered (simple partial seizure) or disturbed (complex partial seizure). Both types may feature a wide variety of motor, sensory, and autonomic symptoms. Partial seizures may be classified by associated clinical features or anatomic location of the seizure focus. A secondary generalized seizure refers to a partial seizure that spreads to involve the brain diffusely. (From Adams et al., Principles of Neurology, 6th ed, pp317) Abdominal Epilepsy,Digestive Epilepsy,Epilepsy, Focal,Epilepsy, Simple Partial,Focal Seizure Disorder,Gelastic Epilepsy,Partial Epilepsy,Partial Seizure Disorder,Seizure Disorder, Partial,Simple Partial Seizures,Amygdalo-Hippocampal Epilepsy,Benign Focal Epilepsy, Childhood,Benign Occipital Epilepsy,Benign Occipital Epilepsy, Childhood,Childhood Benign Focal Epilepsy,Childhood Benign Occipital Epilepsy,Epilepsy, Benign Occipital,Epilepsy, Localization-Related,Epilepsy, Partial,Occipital Lobe Epilepsy,Panayiotopoulos Syndrome,Partial Seizures, Simple, Consciousness Preserved,Rhinencephalic Epilepsy,Seizure Disorder, Focal,Subclinical Seizure,Uncinate Seizures,Abdominal Epilepsies,Amygdalo-Hippocampal Epilepsies,Benign Occipital Epilepsies,Digestive Epilepsies,Disorders, Focal Seizure,Disorders, Partial Seizure,Epilepsies, Abdominal,Epilepsies, Amygdalo-Hippocampal,Epilepsies, Benign Occipital,Epilepsies, Digestive,Epilepsies, Focal,Epilepsies, Gelastic,Epilepsies, Localization-Related,Epilepsies, Occipital Lobe,Epilepsies, Rhinencephalic,Epilepsies, Simple Partial,Epilepsy, Abdominal,Focal Epilepsies,Focal Epilepsy,Focal Seizure Disorders,Gelastic Epilepsies,Lobe Epilepsy, Occipital,Localization-Related Epilepsies,Localization-Related Epilepsy,Occipital Epilepsies, Benign,Occipital Epilepsy, Benign,Occipital Lobe Epilepsies,Partial Epilepsies,Partial Epilepsies, Simple,Partial Seizure Disorders,Partial Seizures, Simple,Rhinencephalic Epilepsies,Seizure Disorders, Focal,Seizure Disorders, Partial,Seizure, Subclinical,Seizure, Uncinate,Seizures, Simple Partial,Seizures, Subclinical,Seizures, Uncinate,Simple Partial Epilepsies,Subclinical Seizures,Uncinate Seizure
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000078334 Lacosamide An acetamide derivative that acts as a blocker of VOLTAGE-GATED SODIUM CHANNELS. It is used as an anticonvulsant, for adjunctive or monotherapy, in the treatment of PARTIAL SEIZURES. N-benzyl-2-acetamido-3-methoxypropionamide,N-benzyl-AcMeOPrNH2,Vimpat,N benzyl 2 acetamido 3 methoxypropionamide,N benzyl AcMeOPrNH2
D000081 Acetamides Derivatives of acetamide that are used as solvents, as mild irritants, and in organic synthesis.

Related Publications

Steve Chung, and Michael R Sperling, and Victor Biton, and Gregory Krauss, and David Hebert, and G David Rudd, and Pamela Doty, and
Adjunctive lacosamide for partial-onset seizures: Efficacy and safety results from a randomized controlled trial.
March 2009, Epilepsia,
Steve Chung, and Michael R Sperling, and Victor Biton, and Gregory Krauss, and David Hebert, and G David Rudd, and Pamela Doty, and
Lacosamide adjunctive therapy for partial-onset seizures: a meta-analysis.
January 2013, PeerJ,
Steve Chung, and Michael R Sperling, and Victor Biton, and Gregory Krauss, and David Hebert, and G David Rudd, and Pamela Doty, and
Adjunctive brivaracetam for refractory partial-onset seizures: a randomized, controlled trial.
August 2010, Neurology,
Steve Chung, and Michael R Sperling, and Victor Biton, and Gregory Krauss, and David Hebert, and G David Rudd, and Pamela Doty, and
Lacosamide: new adjunctive treatment option for partial-onset seizures.
June 2010, Expert opinion on pharmacotherapy,
Steve Chung, and Michael R Sperling, and Victor Biton, and Gregory Krauss, and David Hebert, and G David Rudd, and Pamela Doty, and
[Lacosamide. A new antiepileptic drug as adjunctive therapy in patients with partial-onset seizures].
October 2008, Medizinische Monatsschrift fur Pharmazeuten,
Steve Chung, and Michael R Sperling, and Victor Biton, and Gregory Krauss, and David Hebert, and G David Rudd, and Pamela Doty, and
Lacosamide as adjunctive therapy for partial-onset epileptic seizures: a review of the clinical and economic literature.
July 2011, Current medical research and opinion,
Steve Chung, and Michael R Sperling, and Victor Biton, and Gregory Krauss, and David Hebert, and G David Rudd, and Pamela Doty, and
Lacosamide: an adjunctive agent for partial-onset seizures and potential therapy for neuropathic pain.
November 2009, The Annals of pharmacotherapy,
Steve Chung, and Michael R Sperling, and Victor Biton, and Gregory Krauss, and David Hebert, and G David Rudd, and Pamela Doty, and
Lacosamide: a review of its use as adjunctive therapy in the management of partial-onset seizures.
December 2013, CNS drugs,
Steve Chung, and Michael R Sperling, and Victor Biton, and Gregory Krauss, and David Hebert, and G David Rudd, and Pamela Doty, and
Efficacy and safety of oral lacosamide as adjunctive therapy in adults with partial-onset seizures.
July 2007, Epilepsia,
Steve Chung, and Michael R Sperling, and Victor Biton, and Gregory Krauss, and David Hebert, and G David Rudd, and Pamela Doty, and
Lacosamide: an investigational drug for adjunctive treatment of partial-onset seizures.
January 2008, Drugs of today (Barcelona, Spain : 1998),
Copied contents to your clipboard!