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Lamotrigine therapy for partial seizures: a multicenter, placebo-controlled, double-blind, cross-over trial. 1994

J Messenheimer, and R E Ramsay, and L J Willmore, and R F Leroy, and J J Zielinski, and R Mattson, and J M Pellock, and A M Valakas, and G Womble, and M Risner
Department of Neurology, University of North Carolina at Chapel Hill 27599.

The efficacy and safety of lamotrigine (LTG), a new antiepileptic drug (AED), were evaluated in a multicenter, randomized, double-blind, placebo-controlled, cross-over study of 98 patients with refractory partial seizures. Each treatment period lasted 14 weeks. Most patients were titrated to a LTG maintenance dose of 400 mg/day. Seizure frequency with LTG decreased by > or = 50%, as compared with placebo, in one fifth of patients. Overall median seizure frequency decreased by 25% with LTG as compared with placebo (p < 0.001). With LTG, the number of seizure days decreased by 18% as compared with placebo (p < 0.01), and investigator global evaluation of overall patient clinical status favored LTG by 2:1 (p = 0.013). Plasma LTG concentrations appeared to be linearly related to dosage. LTG had no clinically important effects on the plasma concentrations of concomitant AEDs. Adverse experiences were generally minor and most frequently were CNS-related (e.g., ataxia, dizziness, diplopia, headache). Most were transient and resolved without discontinuing treatment. Five patients withdrew as a result of adverse experiences while receiving LTG, including 3 patients with rash. One placebo patient was also withdrawn because of rash. The addition of twice-daily LTG to an existing AED regimen was safe, effective, and well tolerated in these medically refractory partial seizure patients.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D010919 Placebos Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. Sham Treatment
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
D004334 Drug Administration Schedule Time schedule for administration of a drug in order to achieve optimum effectiveness and convenience. Administration Schedule, Drug,Administration Schedules, Drug,Drug Administration Schedules,Schedule, Drug Administration,Schedules, Drug Administration
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
D000077213 Lamotrigine A phenyltriazine compound, sodium and calcium channel blocker that is used for the treatment of SEIZURES and BIPOLAR DISORDER. 3,5-Diamino-6-(2,3-dichlorophenyl)-1,2,4-triazine,3,5-Diamino-6-(2,3-dichlorophenyl)-as-triazine,BW-430C,Crisomet,Labileno,Lamictal,Lamiktal,BW 430C,BW430C

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