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Eslicarbazepine

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181. Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs

anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine, eslicarbazepine acetate) Drug: anti-epileptic drug Patient who initiate anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine, eslicarbazepine acetate) Biological: Blood sampling Blood sampling is done for Patient who initiate anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine (...) , oxcarbazepine, eslicarbazepine acetate) Outcome Measures Go to Primary Outcome Measures : Number of patients with viral reactivation of Epstein-Barr Virus [ Time Frame: 3 Months ] Number of patients with viral reactivation of Epstein-Barr Virus is evaluated in patients initiating an anti-epileptic treatment Number of patients with viral reactivation of Human Herpes Virus 6 [ Time Frame: 3 Months ] Number of patients with viral reactivation of Human Herpes Virus 6 is evaluated in patients initiating an anti

2015 Clinical Trials

182. Buparlisib in Melanoma Patients Suffering From Brain Metastases (BUMPER)

., obstructive airways diseases), eye drops or local injections (e.g., intra-articular) Patient taking an enzyme-inducing anti-epileptic drug (EIAED): phenobarbital, phenytoin, fosphenytoin, primidone, rufinamide carbamazepine, oxcarbazepine, eslicarbazepine, felbamate, and topiramate (only when daily dose exceeds 200 mg). Participant must be off any EIAEDs for at least two weeks prior to starting study Requirement of more than 4 mg dexamethasone daily Patient is being treated at start of study treatment

2015 Clinical Trials

183. Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL)

. ClinicalTrials.gov Identifier: NCT02491073 Recruitment Status : Completed First Posted : July 7, 2015 Results First Posted : February 5, 2018 Last Update Posted : February 7, 2018 Sponsor: Sunovion Information provided by (Responsible Party): Sunovion Study Details Study Description Go to Brief Summary: The purpose of this research study is to determine if the blood tests used to measure free thyroid hormone levels are affected by a drug called eslicarbazepine acetate. To determine if eslicarbazepine acetate (...) interferes with these blood tests, blood samples will be analysed so that researchers can compare different types of lab tests that measure these thyroid hormones. Half of the people who participate in this study will already be taking eslicarbazepine acetate either as a study drug or as a prescription (Part 1) and the other half will be people who do not take eslicarbazepine acetate (Part 2). Condition or disease Intervention/treatment Epilepsy Other: blood draw Detailed Description: Part 1 of the study

2015 Clinical Trials

184. Oxcarbazepine and its active metabolite, (S)-licarbazepine, exacerbate seizures in a mouse model of genetic generalized epilepsy. (PubMed)

Oxcarbazepine and its active metabolite, (S)-licarbazepine, exacerbate seizures in a mouse model of genetic generalized epilepsy. Oxcarbazepine (OXC), widely used to treat focal epilepsy, is reported to exacerbate seizures in patients with generalized epilepsy. OXC is metabolized to monohydroxy derivatives in two enantiomeric forms: (R)-licarbazepine and (S)-licarbazepine. Eslicarbazepine acetate is a recently approved antiepileptic drug that is rapidly metabolized to (S)-licarbazepine (...) . It is not known whether (S)-licarbazepine exacerbates seizures. Here, we test whether OXC or either of its enantiomers exacerbates the number of spike-and-wave discharges (SWDs) in mice harboring the human γ-aminobutyric acid A receptor (GABAA)γ2(R43Q) mutation. OXC (20 mg/kg), (S)-licarbazepine (20 mg/kg), and (R)-licarbazepine (20 mg/kg) all significantly increased the number of SWDs, while their duration was unaffected. The potential for (S)-licarbazepine to exacerbate SWDs suggests that eslicarbazepine

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2014 Epilepsia

185. 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

186. 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

187. 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

188. 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

189. 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

190. 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

191. 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

192. 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

193. A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic Profile and CNS Effects of BIA 2-093

daily) BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets. Drug: Placebo Other Name: PLC, Placebo Drug: BIA 2-093 Other Name: ESL, Eslicarbazepine acetate Experimental: Group 2 - 400 mg b.i.d. BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets. Drug: Placebo Other Name: PLC, Placebo Drug: BIA 2-093 Other Name: ESL, Eslicarbazepine acetate Experimental: Group 3- 800 mg o.d. (once daily) BIA 2-093 200mg with 200 ml potable (...) water. Identical placebo administered as oral tablets. Drug: Placebo Other Name: PLC, Placebo Drug: BIA 2-093 Other Name: ESL, Eslicarbazepine acetate Experimental: Group 4 - either 800 mg b.i.d or 1200 mg o.d. BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets. Drug: Placebo Other Name: PLC, Placebo Drug: BIA 2-093 Other Name: ESL, Eslicarbazepine acetate Outcome Measures Go to Primary Outcome Measures : Total Number of Adverse Events [ Time Frame: up to 20

2014 Clinical Trials

194. 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

195. The Tolerability and Effect of Food on the Pharmacokinetics of a Single 800 mg Oral Dose of BIA 2-093

BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting. Fed and fasting periods were separated by a washout period Drug: BIA 2-093 Other Name: ESL, Eslicarbazepine acetate Outcome Measures Go to Primary Outcome Measures : Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 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 of BIA 2-093 Secondary Outcome Measures : Time of Occurrence (...) : Plan to Share IPD: Undecided Layout table for additional information Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Keywords provided by Bial - Portela C S.A.: BIA 2-093 Eslicarbazepine acetate Additional relevant MeSH terms: Layout table for MeSH terms Eslicarbazepine acetate Anticonvulsants Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

2014 Clinical Trials

196. A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093

MeSH terms: Layout table for MeSH terms Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Eslicarbazepine acetate Anticonvulsants Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action

2014 Clinical Trials

197. Pharmacokinetics, Efficacy and Tolerability of BIA 2-093

C S.A. Study Details Study Description Go to Brief Summary: The purpose of this study is to characterize the pharmacokinetics of Eslicarbazepine acetate in children and adolescents with epilepsy. Condition or disease Intervention/treatment Phase Epilepsy Drug: BIA 2-093 (Eslicarbazepine acetate) Phase 2 Detailed Description: This clinical study was planned to be performed as an open-label, single-centre, multiple-dose study, in 30 paediatric epileptic patients distributed by 3 age groups of 10 (...) patients each: 2-6 years [Group 1], 7-11 years [Group 2], and 12-17 years [Group 3]. The study was constituted by a 4-week baseline phase, followed by 3 consecutive 4-week treatment periods with Eslicarbazepine acetate in which patients received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day (weeks 1-4), 15 mg/kg/day (weeks 5-8) and 30 mg/kg/day or 1800 mg/day, whichever less (weeks 9-12). At the end of each 4-week treatment period, patients were hospitalised

2014 Clinical Trials

198. To Evaluate the Effect of Perampanel on Objective and Subjective Sleep in Subjects With Insomnia and Partial Onset Seizures

or major depressive disorder within 2 years before Screening based on clinical history Subjects on strong cytochrome P450 (CYP) 3A inducers other than AEDs (eg, rifampin, St. John's Wort) Subjects on EIAEDs: carbamazepine, oxcarbazepine, and phenytoin or eslicarbazepine (presumed EIAED) Using a prescription or over the counter medication for the purpose of treating sleep disturbance, including sedating antihistamines, within 14 days before dosing Transmeridian travel across more than 3 time zones

2014 Clinical Trials

199. The efficacy and safety of retigabine and other adjunctive treatments for refractory partial epilepsy: a systematic review and indirect comparison.

of RTG and selected AEDs approved for use in a similar position in the management pathway of partial epilepsy (eslicarbazepine acetate [ESL], lacosamide [LCM], pregabalin [PGB], tiagabine [TGB] and zonisamide [ZNS]). Using conventional and network meta-analyses as appropriate, we report efficacy and tolerability outcomes for each AED versus placebo and the performance of RTG relative to other AEDs.Twenty studies met the inclusion criteria: three each for RTG, ESL, LCM, TGB and ZNS; five for PGB

2014 Seizure

200. 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

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