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Eslicarbazepine

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161. Tolerability of new antiepileptic drugs: a network meta-analysis. (PubMed)

conducted for all therapeutic doses pooled and specifically for high therapeutic doses. Patients treated with non-therapeutic doses of each drug were excluded.A total of 195 RCTs were included in the current analysis, comprising a total of 28,013 patients treated with AEDs and 17,908 patients treated with placebo. RCTs included in the analysis were 8 for brivaracetam; 5 for eslicarbazepine; 22 for gabapentin; 7 for lacosamide; 14 for levetiracetam; 14 for lamotrigine; 6 for oxcarbazepine; 9 (...) for perampanel; 50 for pregabalin; 5 for tiagabine; 36 for topiramate; 7 for zonisamide; 4 for gabapentin-extended formulation (ER); 2 each for levetiracetam-ER, lamotrigine-ER, and topiramate-ER; and 1 each for oxcarbazepine-ER and pregabalin-ER. Brivaracetam, gabapentin, gabapentin-ER, and levetiracetam had a significantly lower withdrawal rate compared to several other AEDs, while eslicarbazepine, lacosamide, oxcarbazepine, and topiramate had a higher withdrawal rate. Perampanel, lamotrigine, pregabalin

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2017 European journal of clinical pharmacology

162. Central Pain Study for ABX-1431

episode within 60 days before the study start. Patients with unresolved infections, AIDS myelopathy, or degenerative neurological conditions. Patient has received the following within 60 days before study start: Intrathecal baclofen. Injection therapies such a botulinum toxin, anesthetic or nerve block to control pain. Plasma exchange Patients taking daily oral opioid drugs are excluded. Patient is taking carbamazepine or oxcarbazine or eslicarbazepine or other potent cytochrome P450 3A4/5 inducers

2017 Clinical Trials

163. A Pediatric Drug Study to Determine the Long-term Safety and Tolerability in Children and Adolescents (4-17 Years in Age) Taking the Drug

in age) taking the drug (elsicarbazepine acetate) Condition or disease Intervention/treatment Phase Epilepsy Drug: Eslicarbazepine acetate Phase 3 Detailed Description: This is a long-term, multicenter, open-label, safety, tolerability, and maintenance of effect study of flexible daily dosing with Eslicarbazepine acetate (ESL) in subjects 4 to 17 years of age with partial onset seizures (POS). The study is designed to enroll subjects to receive ESL as adjunctive treatment with the option to convert (...) information Study Type : Interventional (Clinical Trial) Actual Enrollment : 0 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Masking Description: Open label Primary Purpose: Treatment Official Title: An Open-label Eslicarbazepine Acetate Long-term Safety and Tolerability Study in Children and Adolescents (4 - 17 Years) Actual Study Start Date : July 6, 2017 Actual Primary Completion Date : October 26, 2017 Actual Study Completion Date : October 26, 2017 Resource links

2017 Clinical Trials

164. ZEDEBAC: Zebinix Effects in Dependency of Baseline Conditions

provided by (Responsible Party): Eisai Inc. ( Eisai GmbH ) Study Details Study Description Go to Brief Summary: This is a non interventional prospective study. Centers will enroll adult participants with partial onset seizures with or without secondary generalisation for whom the clinician has decided to initiate eslicarbazepine acetate (ESL) as an adjunctive therapy or monotherapy prior to the decision to take part in this study. Participants to be enrolled into the study will receive ESL either (...) Perspective: Prospective Official Title: An Open, Multicentric, Non-Interventional Observational Study Investigating Retention, Seizure Control and Tolerability in Epilepsy Patients With Partial Onset Seizures Receiving Eslicarbazepine Acetate (ESL) in Different Therapy Situations Actual Study Start Date : July 2015 Estimated Primary Completion Date : October 2018 Estimated Study Completion Date : October 2018 Resource links provided by the National Library of Medicine related topics: related topics

2017 Clinical Trials

165. A Study of a Drug to be Used in Addition With Another Drug to Treat Adults With Uncontrolled Partial-onset Seizures

Posted : April 17, 2017 Last Update Posted : March 5, 2019 Sponsor: Sunovion Information provided by (Responsible Party): Sunovion Study Details Study Description Go to Brief Summary: A study of a drug to be used in addition with another drug to treat adults with Uncontrolled Partial-onset Seizures Condition or disease Intervention/treatment Phase Epilepsy With Partial On-set Seizures Drug: Eslicarbazepine acetate Drug: Eslicarbazepine Acetate Phase 4 Detailed Description: This is a 31-week (...) , multicenter, 2-arm, prospective, open-label, non-randomized, Phase 4 study of eslicarbazepine acetate (ESL) as adjunctive therapy in adult subjects with a diagnosis of epilepsy with POS. Two groups of ESL-naïve subjects will be evaluated. The groups are defined as follows: Arm 1 (ESL as first add-on): This group will include subjects who have been maintained on a regimen consisting of a stable dose of LEV or LTG for at least 1 month (28 days) prior to screening and who have not used any adjunctive

2017 Clinical Trials

166. Interactions between cannabidiol and commonly used antiepileptic drugs. (PubMed)

to determine if the frequency of sedation in participants was related to the mean serum N-desmethylclobazam level, and if aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels were different in participants taking concomitant valproate.Increases in topiramate, rufinamide, and N-desmethylclobazam and decrease in clobazam (all p < 0.01) serum levels were seen with increasing CBD dose. Increases in serum levels of zonisamide (p = 0.02) and eslicarbazepine (p = 0.04) with increasing CBD (...) dose were seen in adults. Except for clobazam and desmethylclobazam, all noted mean level changes were within the accepted therapeutic range. Sedation was more frequent with higher N-desmethylclobazam levels in adults (p = 0.02), and AST/ALT levels were significantly higher in participants taking concomitant valproate (p < 0.01).Significantly changed serum levels of clobazam, rufinamide, topiramate, zonisamide, and eslicarbazepine were seen. Abnormal liver function test results were noted

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2017 Epilepsia

167. Development and pharmacologic characterization of the rat 6 Hz model of partial seizures. (PubMed)

including head nod, jaw clonus, and forelimb clonus.A convulsive current that elicits these seizure behaviors in 97% of rats (CC97 ) was determined using a Probit analysis. Numerous prototype ASDs were evaluated in this model using stimulus intensities of 1.5× and 2× the CC97 , which is comparable to the approach used in the mouse 6 Hz seizure model (e.g., 32 and 44 mA stimulus intensities). The ASDs evaluated include carbamazepine, clobazam, clonazepam, eslicarbazepine, ethosuximide, ezogabine

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2017 Epilepsia

168. Perampanel (epilepsy and seizures) ? Benefit assessment according to §35a Social Code Book V

and older in comparison with the appropriate comparator therapy (ACT). The G-BA specified the following ACT: ? an individual antiepileptic add-on therapy, if medically indicated and if no pharmacoresistance/intolerance and contraindications are known yet, with one of the following drugs: eslicarbazepine (for adults) or gabapentin or lacosamide (for patients aged 16 years and older) or lamotrigine or levetiracetam or oxcarbazepine or pregabalin (for adults) or topiramate or valproic acid or zonisamide (...) Appropriate comparator therapy Extent and probability of added benefit As add-on therapy of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older An individual antiepileptic add-on therapy, if medically indicated and if no pharmacoresistance/intolerance and contraindications are known yet, with one of the following drugs: eslicarbazepine a or gabapentin or lacosamide b or lamotrigine or levetiracetam or oxcarbazepine or pregabalin

2014 Institute for Quality and Efficiency in Healthcare (IQWiG)

169. An Updated Overview on Therapeutic Drug Monitoring of Recent Antiepileptic Drugs (PubMed)

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

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2016 Drugs in R&D

170. 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

171. 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

172. 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

173. 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

174. 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

175. 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

176. 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

177. 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

178. 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

179. 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

180. 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

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