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Eslicarbazepine

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141. A Study of Abemaciclib in Recurrent Glioblastoma

evidence of 1p/19q co-deletion. IDH1/2 mutation in any prior biopsy. Previous therapies Participants who have received prior treatment with a CDK4/6 inhibitor. Participants who have received anti-VEGF targeted agents (e.g. bevacizumab, cediranib, aflibercept, vandetanib, XL184, sunitinib etc). Concomitant medications Participants taking an enzyme-inducing anti-epileptic drug (EIAED): phenobarbital, phenytoin, fosphenytoin, primidone, carbamazepine, oxcarbazepine, eslicarbazepine, rufinamide

2016 Clinical Trials

142. INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)

agents or other agents used in study. Participants taking an enzyme-inducing anti-epileptic drug (EIAED): phenobarbital, phenytoin, fosphenytoin, primidone, carbamazepine, oxcarbazepine, eslicarbazepine, rufinamide, and felbamate. Participant must be off any EIAEDs for at least 7 days prior to planned start of study treatment. A list of EIAED and other inducers of CYP3A4 is provided. Among non-EIAED, caution is recommended with use of valproic acid due to potential for drug interaction. Participants

2016 Clinical Trials

143. An Updated Overview on Therapeutic Drug Monitoring of Recent Antiepileptic Drugs Full Text available with Trip Pro

for variable or nonlinear pharmacokinetics; and can be useful in special populations such as pregnancy. This review examines the potential for TDM of newer AEDs such as eslicarbazepine acetate, felbamate, gabapentin, lacosamide, lamotrigine, levetiracetam, perampanel, pregabalin, rufinamide, retigabine, stiripentol, tiagabine, topiramate, vigabatrin, and zonisamide. We describe the relationships between serum drug concentration, clinical effect, and adverse drug reactions for each AED as well

2016 Drugs in R&D

144. A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome

with: anorectic agents; monoamine-oxidase inhibitors; medications that act via serotonin including serotonin reuptake inhibitors; atomoxetine, or other centrally-acting noradrenergic agonist; or cyproheptadine. Currently receiving or has received stiripentol in the past 21 days prior to Screening. Currently taking carbamazepine, oxcarbamazepine, eslicarbazepine, phenobarbital, or phenytoin, or has taken any of these within the past 30 days. Positive result on tetrahydrocannabinol (THC) or cannabidiol (CBD

2016 Clinical Trials

145. Perampanel for Treatment of Adults With Refractory Focal Epilepsy : a Pilot Study.

) Perampanel +phenobarbital, (2) PMP+valproate, (3) PMP+ lamotrigine, (4) PMP + topiramate, (5) PMP + tiagabine, (6) PMP + levetiracetam, (7) PMP + zonisamide, (8) PMP + pregabalin, (9) PMP + lacosamide, (10) PMP+ clobazam, (11) PMP + ezogabine; and (12) PMP + eslicarbazepine. Each group of 6 will be followed for 12 weeks of baseline observation on baseline medication. Seizure frequency will be counted, using subjects' self-reported seizure diaries. PMP will be titrated to 8-12 mg/day, with the final dose (...) as "add on" medication. Drug: perampanel Each group of 6 patients will be followed for 12 weeks of baseline observation on baseline medication. Seizure frequency will be counted, using subjects' self-reported seizure diaries. Perampanel will be titrated to 8-12 mg/day, with the final dose determined by side effects and tolerability of Perampanel at 8-12 mg/day doses. Titration will occur at the rate of 2 mg/week or two weeks, as tolerated. Other Name: Fycompa Active Comparator: eslicarbazepine After

2016 Clinical Trials

146. Perampanel as Adjunctive Therapy in Pediatrics With Partial Onset Seizures or Primary Generalized Tonic Clonic Seizures

weeks before to Visit 1; in the case where a new AED regimen has been initiated for a participant, the dose must be stable for at least 8 weeks prior to Visit 1. Only 1 EIAED (defined as carbamazepine, phenytoin, oxcarbazepine, or eslicarbazepine) out of the maximum of 3 AEDs is allowed (A vagal nerve stimulator [VNS] will be counted as one of the 3 allowed AEDs.) Exclusion Criteria: Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta human chorionic

2016 Clinical Trials

147. A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome

. Currently taking carbamazepine, oxcarbamazepine, eslicarbazepine, phenobarbital, or phenytoin, or has taken any of these within the past 30 days. Subject is unwilling to refrain from large or daily servings of grapefruits and/or Seville oranges, and their juices beginning with the Baseline Period and throughout the study. A clinically significant condition, or has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to the Screening Visit, other than epilepsy

2016 Clinical Trials

148. An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome

-acting anorectic agents; monoamineoxidase inhibitors; any centrally-acting compound with clinically appreciable amount of serotonin agonist or antagonist properties, including serotonin reuptake inhibition; atomoxetine, or other centrally-acting noradrenergic agonist; cyproheptadine, and/or cytochrome P450 (CYP) 2D6/3A4/2B6 inhibitors/substrates. Currently taking carbamazepine, oxcarbamazepine, eslicarbazepine, phenobarbital, or phenytoin, or has taken any of these within the past 30 days

2016 Clinical Trials

149. A Two-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥2 Years Old and Young Adults With Dravet Syndrome

amount of serotonin agonist or antagonist properties, including serotonin re-uptake inhibition; triptans, atomoxetine, or other centrally-acting noradrenergic agonist; cyproheptadine, and/or CYP 2D6/3A4/2B6 inhibitors/substrates. Subject is currently taking carbamazepine, oxcarbamazepine, eslicarbazepine, phenobarbital, or phenytoin, or has taken any of these within the past 30 days, as maintenance therapy. Subject has a positive result on urine THC Panel or whole blood CBD at the Screening Visit

2016 Clinical Trials

150. 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

151. Genetic, Dietary and Environmental Influences on Vitamin D Metabolism

inducers including: Dexamethasone, Enzalutamide, Lumacaftor, Mitotane, St. John's wort, Bexarotene, Bosentan, Dabrafenib, Efavirenz, Eslicarbazepine, Etravirine, Modafinil Other drugs that will cause a participant to be excluded include: Cholestyramine, Ferric carboxymaltose (treatment of iron deficiency anemia), Dapsone, Metformin Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using

2015 Clinical Trials

152. 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

153. 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

154. Does medical marijuana work? The answer is (mostly) “no” and “we don’t know”

research. ☛ List of brain tumor patients who died due to opinions based on gossip. Drug Worriers preferred methods of treatment… Epileptic seizures: Aptiom (eslicarbazepine acetate) Who’s Really Fighting Legal Weed ☛ 3/4th of a Century of Gossip and Gutter Science ☛ A Very Lucrative Evil Hoax ☛ Only 13% of the medical schools surveyed mention the endocannabinoid science to our future doctors. Note that’s “mention” GanjaRx. None of the Med Schools teach students, future doctors. Censorship is the same

2015 Respectful Insolence

155. Oxcarbazepine and its active metabolite, (S)-licarbazepine, exacerbate seizures in a mouse model of genetic generalized epilepsy. Full Text available with Trip Pro

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

2014 Epilepsia

156. 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

157. 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

158. 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

159. 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

160. 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

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