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Eslicarbazepine

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161. A Single Centre, Phase I, Double-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetic Profile and Effects on EEG of Single Rising Oral Doses of BIA 2-093

to Healthy Male Adult Volunteers. Study Start Date : July 2000 Actual Primary Completion Date : October 2000 Actual Study Completion Date : October 2000 Resource links provided by the National Library of Medicine related topics: related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: Group 1 (20 mg) Drug: BIA 2-093 BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg Other Name: ESL, Eslicarbazepine acetate Drug: Placebo Identical placebo (...) administered as oral tablets with 200 ml potable water. Other Name: PLC Experimental: Group 2 (50 mg) Drug: BIA 2-093 BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg Other Name: ESL, Eslicarbazepine acetate Drug: Placebo Identical placebo administered as oral tablets with 200 ml potable water. Other Name: PLC Experimental: Group 3 (100 mg) Drug: BIA 2-093 BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg Other Name: ESL, Eslicarbazepine acetate Drug: Placebo

2014 Clinical Trials

162. Single-dose and Steady-state Pharmacokinetics of BIA 2-093 and Its Metabolites

or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose. Drug: BIA 2-093 During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose. Other Name: Eslicarbazepine acetate Experimental: Young subjects 16 (...) young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose. Drug: BIA 2-093 During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose. Other Name: Eslicarbazepine

2014 Clinical Trials

163. The Effect of BIA 2-093 on the Steady-state Pharmacokinetics of Digoxin

: BIA 2-093 BIA 2-093 1200 mg (2 tablets 600 mg) ESL, Eslicarbazepine acetate Concomitantly with a dose of digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day). Drug: BIA 2-093 BIA 2-093 1200 mg once-daily Other Name: ESL, Eslicarbazepine acetate Drug: Digoxin Digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day). Other Name: Lanoxin™ Placebo Comparator: Placebo Placebo (2 tablets matching BIA 2-093 600 mg tablets) PLC, Placebo Concomitantly with a dose (...) information Responsible Party: Bial - Portela C S.A. ClinicalTrials.gov Identifier: Other Study ID Numbers: BIA-2093-107 First Posted: June 24, 2014 Results First Posted: December 31, 2014 Last Update Posted: December 31, 2014 Last Verified: December 2014 Keywords provided by Bial - Portela C S.A.: Eslicarbazepine acetate BIA 2-093 Additional relevant MeSH terms: Layout table for MeSH terms Digoxin Eslicarbazepine acetate Anti-Arrhythmia Agents Cardiotonic Agents Enzyme Inhibitors Molecular Mechanisms

2014 Clinical Trials

164. The Effect of BIA 2-093 on the Steady-state Pharmacodynamic and Pharmacokinetic Profiles of Warfarin

Profiles of Warfarin in Healthy Volunteers Study Start Date : May 2002 Actual Primary Completion Date : July 2002 Actual Study Completion Date : July 2002 Resource links provided by the National Library of Medicine related topics: related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: Group 1 Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin Drug: BIA 2-093 Other Name: ESL, Eslicarbazepine acetate Drug: Warfarin Other Name: Uniwarfin (...) : Layout table for MeSH terms Warfarin Eslicarbazepine acetate Anticoagulants Anticonvulsants Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

2014 Clinical Trials

165. Single-dose Pharmacokinetics and Relative Bioavailability of an Oral Suspension and Two Tablet Formulations of BIA 2-093

50 mg/mL Other Name: ESL, Eslicarbazepine acetate Drug: BIA 2-093 200 mg tablet Other Name: ESL, Eslicarbazepine acetate Drug: BIA 2-093 800 mg tablet Other Name: ESL, Eslicarbazepine acetate Experimental: Group B st period - One 800 mg tablet nd period - 16 mL oral suspension 50 mg/mL rd period - Four 200 mg tablets Drug: BIA 2-093 oral suspension 50 mg/mL Other Name: ESL, Eslicarbazepine acetate Drug: BIA 2-093 200 mg tablet Other Name: ESL, Eslicarbazepine acetate Drug: BIA 2-093 800 mg tablet (...) Other Name: ESL, Eslicarbazepine acetate Experimental: Group C st period - Four 200 mg tablets nd period - One 800 mg tablet rd period - 16 mL oral suspension 50 mg/mL Drug: BIA 2-093 oral suspension 50 mg/mL Other Name: ESL, Eslicarbazepine acetate Drug: BIA 2-093 200 mg tablet Other Name: ESL, Eslicarbazepine acetate Drug: BIA 2-093 800 mg tablet Other Name: ESL, Eslicarbazepine acetate Outcome Measures Go to Primary Outcome Measures : Cmax - the Maximum Plasma Concentration [ Time Frame: Blood

2014 Clinical Trials

166. An Open-label, Multiple-dose, Single-centre Study, Investigating the Pharmacokinetics of BIA 2-093

Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Subjects with moderate hepatic impairment This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls Drug: BIA 2-093 Other Name: Eslicarbazepine Acetate subjects - healthy controls This was an open-label, multiple-dose, single-centre study in 2 groups of subjects (...) : subjects with moderate hepatic impairment and healthy controls Drug: BIA 2-093 Other Name: Eslicarbazepine Acetate Outcome Measures Go to Primary Outcome Measures : Area Under the Plasma Concentration Versus Time Curve, AUC(0-tlast). [ Time Frame: pre-dose and 1, 2, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 7, 9, 12 and 24 hours post-dose. ] Day 1 - Area under the plasma concentration versus time curve, AUC(0-tlast). BIA 2-194, 2-195 Glucoronide, Oxcarbazepine, BIA 2-093 Glucoronide, 2-194

2014 Clinical Trials

167. Effect of BIA 2-093 on the Pharmacokinetics of a Combined Oral Contraceptive.

Eslicarbazepine acetate Reproductive Control Agents Physiological Effects of Drugs Contraceptive Agents, Female Anticonvulsants Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

2014 Clinical Trials

168. An Open-label, Single-dose, Single-centre Study, Investigating the Pharmacokinetics of BIA 2-093

terms Eslicarbazepine acetate Anticonvulsants Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

2014 Clinical Trials

169. Buparlisib (BKM120) In Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Recurrent/Refractory Secondary Central Nervous System Lymphoma (SCNSL)

, primidone, carbamazepine, oxcarbazepine, eslicarbazepine, rufinamide, and felbamate. Participates must be off of any EIAED for a least two weeks prior to starting the study drug Patient is taking a drug known to be a strong inhibitor or inducers of the isoenzyme CYP3A. Participants must be off a strong CYP3A inhibitors and inducers for at least two weeks prior to starting the study drug. Patient is taking a drug with known risk to promote QT prolongation and Torsade de Pointes Patient is currently using

2014 Clinical Trials

170. Partial Epilepsies (Treatment)

, brivaracetam, oxcarbazepine, eslicarbazepine, and vigabatrin. Most of these newer AEDs are approved as adjuncts for partial epilepsy. Note that most epilepsy specialists believe that all AEDs that have been approved by the FDA for adjunctive therapy may be effective as monotherapy, and their prescribing practices reflect this. After they are on the market, many AEDs (eg, carbamazepine, valproic acid, levetiracetam, lamotrigine) are made available in a long-acting or extended-release preparation that may (...) perampanel for refractory partial-onset seizures. Neurology . 2012 May 1. 78(18):1408-15. . Hufnagel A, Ben-Menachem E, Gabbai AA, Falcão A, Almeida L, Soares-da-Silva P. Long-term safety and efficacy of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy: results of a 1-year open-label extension study. Epilepsy Res . 2013 Feb. 103(2-3):262-9. . Halász P, Cramer JA, Hodoba D, Czlonkowska A, Guekht A, Maia J, et al. Long-term efficacy and safety

2014 eMedicine.com

171. Antiepileptic Drugs: An overview

, gastrointestinal (GI) disturbances, and alopecia are the most commonly reported adverse effects. The allergic rash is similar to the one caused by CBZ. Dose-related adverse effects include fatigue, headache, dizziness, and ataxia. Hyponatremia is mild and can be corrected by fluid restriction. Hyponatremia is uncommon in children younger than 17 years, but it occurs in 2.5% of adults and 7.4% of the elderly. Idiosyncratic reactions appear to be less common than with CBZ. Eslicarbazepine (Aptiom) is a prodrug (...) that is activated to eslicarbazepine (S-licarbazepine), the major active metabolite of oxcarbazepine. It is indicated as either adjunctive treatment or monotherapy for partial-onset seizures in adults and children 4 years and older. The initial adult dose is 400 mg PO once daily for 1 week, then increased to 800 mg PO once daily (the recommended maintenance dose). Some patients may benefit from 1,200 mg/day (maximum dose). An increase to 1,200 mg/day should only be initiated after patients tolerate 800 mg/day

2014 eMedicine.com

172. Seizures and Epilepsy: Overview and Classification (Treatment)

anticonvulsants (eg, lamotrigine, topiramate, valproic acid, zonisamide) have multiple mechanisms of action, and some (eg, phenytoin, carbamazepine, ethosuximide) have only 1 known mechanism of action. Anticonvulsants can be divided into large groups based on their mechanisms, as follows: Blockers of repetitive activation of the sodium channel: Phenytoin, carbamazepine, oxcarbazepine, eslicarbazepine, lamotrigine, topiramate Enhancers of slow inactivation of the sodium channel: Lacosamide, rufinamide Gamma

2014 eMedicine.com

173. Partial Epilepsies (Overview)

A, Almeida L, Soares-da-Silva P. Long-term safety and efficacy of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy: results of a 1-year open-label extension study. Epilepsy Res . 2013 Feb. 103(2-3):262-9. . Halász P, Cramer JA, Hodoba D, Czlonkowska A, Guekht A, Maia J, et al. Long-term efficacy and safety of eslicarbazepine acetate: results of a 1-year open-label extension study in partial-onset seizures in adults with epilepsy. Epilepsia

2014 eMedicine.com

174. Partial Epilepsies (Follow-up)

, brivaracetam, oxcarbazepine, eslicarbazepine, and vigabatrin. Most of these newer AEDs are approved as adjuncts for partial epilepsy. Note that most epilepsy specialists believe that all AEDs that have been approved by the FDA for adjunctive therapy may be effective as monotherapy, and their prescribing practices reflect this. After they are on the market, many AEDs (eg, carbamazepine, valproic acid, levetiracetam, lamotrigine) are made available in a long-acting or extended-release preparation that may (...) perampanel for refractory partial-onset seizures. Neurology . 2012 May 1. 78(18):1408-15. . Hufnagel A, Ben-Menachem E, Gabbai AA, Falcão A, Almeida L, Soares-da-Silva P. Long-term safety and efficacy of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy: results of a 1-year open-label extension study. Epilepsy Res . 2013 Feb. 103(2-3):262-9. . Halász P, Cramer JA, Hodoba D, Czlonkowska A, Guekht A, Maia J, et al. Long-term efficacy and safety

2014 eMedicine.com

175. Antiepileptic Drugs: An overview

, gastrointestinal (GI) disturbances, and alopecia are the most commonly reported adverse effects. The allergic rash is similar to the one caused by CBZ. Dose-related adverse effects include fatigue, headache, dizziness, and ataxia. Hyponatremia is mild and can be corrected by fluid restriction. Hyponatremia is uncommon in children younger than 17 years, but it occurs in 2.5% of adults and 7.4% of the elderly. Idiosyncratic reactions appear to be less common than with CBZ. Eslicarbazepine (Aptiom) is a prodrug (...) that is activated to eslicarbazepine (S-licarbazepine), the major active metabolite of oxcarbazepine. It is indicated as either adjunctive treatment or monotherapy for partial-onset seizures in adults and children 4 years and older. The initial adult dose is 400 mg PO once daily for 1 week, then increased to 800 mg PO once daily (the recommended maintenance dose). Some patients may benefit from 1,200 mg/day (maximum dose). An increase to 1,200 mg/day should only be initiated after patients tolerate 800 mg/day

2014 eMedicine.com

176. Seizures and Epilepsy: Overview and Classification (Follow-up)

anticonvulsants (eg, lamotrigine, topiramate, valproic acid, zonisamide) have multiple mechanisms of action, and some (eg, phenytoin, carbamazepine, ethosuximide) have only 1 known mechanism of action. Anticonvulsants can be divided into large groups based on their mechanisms, as follows: Blockers of repetitive activation of the sodium channel: Phenytoin, carbamazepine, oxcarbazepine, eslicarbazepine, lamotrigine, topiramate Enhancers of slow inactivation of the sodium channel: Lacosamide, rufinamide Gamma

2014 eMedicine.com

177. Frontal Lobe Epilepsy (Follow-up)

-seizure medications include gabapentin, lamotrigine, topiramate, levetiracetam, zonisamide, oxcarbazepine, pregabalin, lacosamide, clobazam, eslicarbazepine, and brivaracetam. Approximately 30% of patients with frontal lobe epilepsy will be refractory to multiple medications, and they may require evaluation for resective surgery. Other options include dietary therapy (ketogenic diet or modified Atkins diet), vagal nerve stimulation, or responsive neurostimulation. Go to for complete information

2014 eMedicine.com

178. Frontal Lobe Epilepsy (Treatment)

-seizure medications include gabapentin, lamotrigine, topiramate, levetiracetam, zonisamide, oxcarbazepine, pregabalin, lacosamide, clobazam, eslicarbazepine, and brivaracetam. Approximately 30% of patients with frontal lobe epilepsy will be refractory to multiple medications, and they may require evaluation for resective surgery. Other options include dietary therapy (ketogenic diet or modified Atkins diet), vagal nerve stimulation, or responsive neurostimulation. Go to for complete information

2014 eMedicine.com

179. Antiepileptic Drugs: An overview

, gastrointestinal (GI) disturbances, and alopecia are the most commonly reported adverse effects. The allergic rash is similar to the one caused by CBZ. Dose-related adverse effects include fatigue, headache, dizziness, and ataxia. Hyponatremia is mild and can be corrected by fluid restriction. Hyponatremia is uncommon in children younger than 17 years, but it occurs in 2.5% of adults and 7.4% of the elderly. Idiosyncratic reactions appear to be less common than with CBZ. Eslicarbazepine (Aptiom) is a prodrug (...) that is activated to eslicarbazepine (S-licarbazepine), the major active metabolite of oxcarbazepine. It is indicated as either adjunctive treatment or monotherapy for partial-onset seizures in adults and children 4 years and older. The initial adult dose is 400 mg PO once daily for 1 week, then increased to 800 mg PO once daily (the recommended maintenance dose). Some patients may benefit from 1,200 mg/day (maximum dose). An increase to 1,200 mg/day should only be initiated after patients tolerate 800 mg/day

2014 eMedicine.com

180. Partial Epilepsies (Diagnosis)

E, Gabbai AA, Falcão A, Almeida L, Soares-da-Silva P. Long-term safety and efficacy of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy: results of a 1-year open-label extension study. Epilepsy Res . 2013 Feb. 103(2-3):262-9. . Halász P, Cramer JA, Hodoba D, Czlonkowska A, Guekht A, Maia J, et al. Long-term efficacy and safety of eslicarbazepine acetate: results of a 1-year open-label extension study in partial-onset seizures

2014 eMedicine.com

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