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Eslicarbazepine

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181. 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

182. 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

183. Pediatric Schizophrenia Efficacy and Safety Study

within 120 days of randomization. Use of any antipsychotic medication (other than study drug), carbamazepine, oxcarbazepine, eslicarbazepine acetate, or fluvoxamine, within 3 days prior to randomization (7 days prior to randomization for aripiprazole) and until follow-up. Has a prolactin concentration ≥ 100 ng/mL at screening, or has a history of pituitary adenoma. At screening or Baseline the subject answers "yes" to "Suicidal Ideation" Items 4 or 5 on the C-SSRS. Subject is considered

2013 Clinical Trials

184. A Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 In Healthy Volunteers

SINGLE AND MULTIPLE HIGH DOSE REGIMENS OF BIA 2-093 IN HEALTHY VOLUNTEERS Study Start Date : October 2004 Actual Primary Completion Date : December 2004 Actual Study Completion Date : December 2004 Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: BIA 2-093 - 1800 mg (Group 1) 3 tablets of BIA 2-093 600 mg Drug: BIA 2-093 - 1800 mg (Group 1) 3 tablets of BIA 2-093 Other Name: Eslicarbazepine (...) acetate Experimental: BIA 2-093 - 2400 mg (Group 2) 4 tablets of BIA 2-093 600 mg Drug: BIA 2-093 - 2400 mg (Group 2) 4 tablets of BIA 2-093 600 mg Other Name: Eslicarbazepine acetate Placebo Comparator: Placebo placebo tablets Drug: Placebo placebo tablets Other Name: sugar pills Outcome Measures Go to Primary Outcome Measures : Number of Adverse Events Reported [ Time Frame: 3 weeks ] investigate the tolerability of two single- and multiple-dose regimens of BIA 2-093 (1800 mg and 2400 mg)considering

2013 Clinical Trials

185. The Effect of BIA 2-093 on the Steady-state Pharmacokinetic Profile of Phenytoin in Patients

by the study centre.) First Posted : June 17, 2013 Last Update Posted : February 27, 2014 Sponsor: Bial - Portela C S.A. Information provided by (Responsible Party): Bial - Portela C S.A. Study Details Study Description Go to Brief Summary: The purpose of this study is determine the interaction of eslicarbazepine acetate (ESL, BIA 2-093) on the steadystate pharmacokinetics of phenytoin in patients and to evaluate the tolerability and safety of ESL administered concomitantly with phenytoin in patients (...) . Condition or disease Intervention/treatment Phase Epilepsy Drug: Eslicarbazepine acetate Drug: phenytoin Drug: Placebo Phase 1 Detailed Description: This study was planned as a single-dose, open label phase (Phase A) followed by a multiple-dose, double-blind, randomised, placebo-controlled, two-way crossover phase (Phase B) study in patients taking phenytoin. Phase B consisted of two 14-day treatment periods separated by a washout period of 10 to 15 days. Subjects continued their usual phenytoin scheme

2013 Clinical Trials

186. Double-blind Study in Paediatric Epileptic to Compare the Subject Preference for ESL Suspension Formulation With Alternative Flavours

Day, all children will be given 3 different flavoured samples of Eslicarbazepine acetate (ESL) oral suspension for tasting, in the sequence to which they were randomised, in a double-blind, standardized setting. Each sample will consist of 2.5 mL and is to be given with a spoon in a double-blind manner, and is not to be swallowed. After tasting and spitting out each sample the child will be asked to rate the taste on a 10 cm visual analogue scale incorporating a facial hedonic scale. At the end (...) /treatment Experimental: ESL Banana taste Subjects were to be enrolled until there were at least 30 evaluable subjects (of whom at least 60% were <7 years of age). Evaluable subjects were those who completed 3 Visual analogue scale (VAS), 1 for each of the 3 tasting steps with the 3 flavoured oral suspensions. Drug: ESL Banana taste oral suspension with Banana flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses. Other Name: Eslicarbazepine acetate (ESL) Experimental: ESL Grape

2013 Clinical Trials

187. Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy

): GlaxoSmithKline Study Details Study Description Go to Brief Summary: There are a number of anti-epileptic drugs available for the treatment of partial onset seizures in patients with epilepsy. This study is a systematic review of the published literature on anti-epileptic drugs and is designed to compare the relative effectiveness and tolerability of a selection of them with retigabine. The drugs chosen for this comparison were lacosamide, pregabalin, tiagabine, zonisamide and eslicarbazepine. They were (...) : zonisamide Drug: pregabalin Drug: eslicarbazepine Study Design Go to Layout table for study information Study Type : Observational Actual Enrollment : 6498 participants Time Perspective: Retrospective Official Title: Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy Study Start Date : September 2010 Actual Primary Completion Date : March 2011 Actual Study Completion Date : July 2011 Resource links provided by the National Library of Medicine related topics: related topics

2012 Clinical Trials

188. Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

Intervention/treatment Experimental: Group A BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period BIA 2-093 450 mg od - BIA 2-093 450 mg bid - OXC 900 mg bid Drug: BIA 2-093 Other Name: ESL, Eslicarbazepine acetate Drug: Oxcarbazepine Other Name: OXC, Trileptal® Experimental: Group B BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period BIA 2-093 (...) 450 mg bid - OXC 450 mg bid - BIA 2-093 900 mg od Drug: BIA 2-093 Other Name: ESL, Eslicarbazepine acetate Drug: Oxcarbazepine Other Name: OXC, Trileptal® Experimental: Group C oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period OXC 450 mg bid - BIA 2-093 900 mg od - BIA 2-093 450 mg bid Drug: BIA 2-093 Other Name: ESL, Eslicarbazepine acetate Drug: Oxcarbazepine Other Name: OXC, Trileptal® Outcome Measures Go

2012 Clinical Trials

189. Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: Group 1 BIA 2-093 + Oxcarbazepine Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine Drug: BIA 2-093 Tablets containing BIA 2-093 in doses of 300 and 600 mg Other Name: Eslicarbazepine acetate Drug: Oxcarbazepine Tablets containing 300 mg and 600 mg of Trileptal® Other Name: Trileptal® Active Comparator: Group 2 Oxcarbazepine + BIA 2-093 Period 1 - Subjects (...) recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093 Drug: BIA 2-093 Tablets containing BIA 2-093 in doses of 300 and 600 mg Other Name: Eslicarbazepine acetate Drug: Oxcarbazepine Tablets containing 300 mg and 600 mg of Trileptal® Other Name: Trileptal® Outcome Measures Go to Primary Outcome Measures : Maximum Drug Concentration (Cmax) [ Time Frame: at pre-dose, ½, 1, 1½, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72 and 96 hours post-dose ] Maximum observed plasma concentration

2012 Clinical Trials

190. Drug Treatment of Seizures

tonic-clonic seizures Carbamazepine Lamotrigine Levetiracetam Oxcarbazepine Fosphenytoin Phenytoin Topiramate First-line monotherapy Divalproex Eslicarbazepine Gabapentin Lacosamide Perampanel Pregabalin Valproate Zonisamide 2nd-line monotherapy or adjunctive therapy Clobazam Felbamate Tiagabine Vigabatrin 3rd-line monotherapy or adjunctive therapy Phenobarbital Although effective, often considered less desirable because it is sedating and can cause behavioral problems in children Typical nonmotor (...) commonly used antiseizure drugs. Because hepatic side effects are possible, patients taking divalproex should have liver function tests every 3 mo for 1 yr; if serum transaminases or ammonia levels increase significantly (> 2 times the upper limit of normal), the drug should be stopped. An increase in ammonia up to 1.5 times the upper limit of normal can be tolerated safely. Eslicarbazepine Eslicarbazepine is indicated for treatment of focal-onset seizures as monotherapy or adjunctive therapy. Unlike

2013 Merck Manual (19th Edition)

191. Drugs in Pregnancy

(brivaracetam, eslicarbazepine ) are available; there is little to no information about their effects during pregnancy. ‡ The European Society for Medical Oncology (ESMO) has published guidelines for diagnosis, treatment, and follow-up of cancer during pregnancy. Generally, if chemotherapy is indicated, it should not be given during the1st trimester but may begin during the 2nd trimester; the last chemotherapy dose should be given ≥ 3 wk before anticipated delivery, and chemotherapy should not be given

2013 Merck Manual (19th Edition)

192. eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam

is taking levetiracetam (LEV) in combination with 1 sodium channel blocking antiepileptic drug (defined as carbamazepine, lamotrigine, oxcarbazepine, phenytoin, or eslicarbazepine) as adjunctive treatment for epilepsy The minimum required seizure frequency during the 8-week Retrospective Seizure Baseline is on average ≥ 2 partial-onset seizures per 28 days with at least 1 seizure per 4 week period within the 8-week Retrospective Seizure Baseline. Additionally, subjects must experience at least 1 seizure

2011 Clinical Trials

193. Current and Emerging Therapies for the Management of Bipolar Disorders Full Text available with Trip Pro

, carbamazepine, nearly all antipsychotics), acute bipolar depression (lamotrigine, quetiapine, olanzapine/fluoxetine combination), and relapse prevention (lithium, lamotrigine, divalproex, most second generation antipsychotics). There are also novel treatments that are being studied for all three phases. These include eslicarbazepine, cariprazine, MEM-1003, memantine, tamoxifen and pentazocine for acute mania; pramipexole, modafinil, armodafinil, divalproex, lurasidone, agomelatine, cariprazine

2011 Journal of central nervous system disease

194. Phase II Study of BKM120 for Subjects With Recurrent Glioblastoma

, oxcarbazepine, eslicarbazepine, rufinamide, and felbamate. Participant must be off any EIAEDs for at least two weeks prior to starting study drug. A list of EIAED and other inducers of CYP3A4 is provided in Table C-3 of Appendix C of the protocol. Participants taking a drug known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A (protoocol Appendix C). Participant must be off CYP3A inhibitors and inducers for at least two weeks prior to starting study drug. NOTE: participants must avoid

2011 Clinical Trials

195. The Therapeutic Effects of Topiramate and Metformin on Second Generation Antipsychotics-induced Obesity

(Olanzapine, Clozapine, Quetiapine, Risperidone, Amisulpride, Zotepine) Exclusion Criteria: Allergy to metformin or topiramate Currently taking metformin or topiramate Currently taking drugs that may interact with topiramate, including carbamazepine, eslicarbazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, amitriptyline, lithium, metformin, propranolol, and sumatriptan. Being pregnant or planning to become pregnant during the study period, History of hypertension, DM, liver or renal function

2011 Clinical Trials

196. Therapeutic Drug Monitoring of the Newer Anti-Epilepsy Medications Full Text available with Trip Pro

Therapeutic Drug Monitoring of the Newer Anti-Epilepsy Medications In the past twenty years, 14 new antiepileptic drugs have been approved for use in the United States and/or Europe. These drugs are eslicarbazepine acetate, felbamate, gabapentin, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, rufinamide, stiripentol, tiagabine, topiramate, vigabatrin and zonisamide. In general, the clinical utility of therapeutic drug monitoring has not been established in clinical trials

2010 Pharmaceuticals

197. Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children

Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more (...) studies before adding more. Eslicarbazepine Acetate (BIA 2 093) as Therapy for Refractory Partial Seizures in Children The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT00988156 Recruitment Status : Completed First Posted : October 2, 2009 Results First Posted : July 17, 2014 Last Update Posted

2009 Clinical Trials

198. Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects

Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum (...) number of saved studies (100). Please remove one or more studies before adding more. Effect of Repeated Administration of Eslicarbazepine Acetate on the Pharmacokinetics of Simvastatin in Healthy Subjects The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT00987558 Recruitment Status : Completed First

2009 Clinical Trials

199. Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures

Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved (...) studies (100). Please remove one or more studies before adding more. Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT00988429 Recruitment Status : Active, not recruiting First Posted

2009 Clinical Trials

200. Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers

Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more (...) studies before adding more. Effect of Eslicarbazepine Acetate on the Pharmacokinetics of Metformin in Healthy Volunteers The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT00971295 Recruitment Status : Completed First Posted : September 3, 2009 Results First Posted : December 16, 2014 Last Update Posted

2009 Clinical Trials

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