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141. Brivaraceta

that the indirect comparisons on brivaracetam versus lacosamide, eslicarbazepine and the joint analysis of the studies on lacosamide and eslicarbazepine submitted by the pharmaceutical company (hereinafter referred to as “the company”) in the dossier were not usable [1]. On the one hand, not all studies with brivaracetam were relevant for the benefit assessment; on the other, most studies included by the company were not sufficiently similar for the indirect comparisons. In addition, the company had

2017 Institute for Quality and Efficiency in Healthcare (IQWiG)

142. Systematic Adverse Drug Reaction Monitoring of Patients Under Newer Antiepileptic Drugs Using Routine Clinical Data of Inpatients (PubMed)

, lacosamide and eslicarbazepine, under real-life conditions by means of an assessment of routine clinical data of inpatients.Over 2.75 years data of all inpatients receiving one of the newer AEDs were documented. Occurring adverse drug reactions (ADRs) were classified according to the WHO-UMC Causality Assessment concerning their likely relationship to the prescribed AEDs. For each AED, the total number of patients without and with ADRs, assessed as at least possibly related to the particular drug

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2016 Drugs - real world outcomes

143. The Risk of Specific Congenital Anomalies in Relation to Newer Antiepileptic Drugs: A Literature Review (PubMed)

The Risk of Specific Congenital Anomalies in Relation to Newer Antiepileptic Drugs: A Literature Review More information is needed about possible associations between the newer anti-epileptic drugs (AEDs) in the first trimester of pregnancy and specific congenital anomalies of the fetus.We performed a literature review to find signals for potential associations between newer AEDs (lamotrigine, topiramate, levetiracetam, gabapentin, oxcarbazepine, eslicarbazepine, felbamate, lacosamide

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2016 Drugs - real world outcomes

144. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guidelines for CYP2C9 and HLA-B Genotype and Phenytoin Dosing

, eslicarbazepine acetate, and lamotrigine have some evidence linking SJS/TEN with the HLA-B*15:02 allele, and thus caution should be used in choosing alternatives to phenytoin (see Supplementary Material online for details). d Recommended maintenance dose based on patient’s clinical characteristics. 544 VOLUME 96 NUMBER 5 | NOVEMBER 2014 | GuIdelInes HLA-B*15:02 with phenytoin-induced SJS/TEN (P < 3? ×? 10 –4 ; odds ratio = 4.26; 95% confidence interval (CI) = 1.93–9.39) under a fixed (...) carbamazepine and phenytoin, unless the benefits of treating the underlying disease clearly outweigh the risks (see Table 2). Some evidence exists linking SJS/TEN with the HLA-B*15:02 allele in association with the use of alternative medications such as oxcarbazepine, eslicarbazepine acetate, and lamotrigine, and thus caution should be used in choos- ing alternatives to phenytoin (see Supplementary Material online for details). CYP2C9 recommendations. Phenytoin and fosphenytoin dose should first be adjusted

2014 Clinical Pharmacogenetics Implementation Consortium

145. Reference ranges for antiepileptic drugs revisited: a practical approach to establish national guidelines (PubMed)

databases.Reference ranges varied between laboratories for four of 23 available AEDs (lamotrigine, valproate, eslicarbazepine and oxcarbazepine). For four AEDs (brivaracetam, perampanel, stiripentol and sulthiame), reference ranges had not previously been established. In total, 13 reference ranges were either harmonized, updated or newly established. No changes were applied to the remaining 10 AEDs.Updated and harmonized reference ranges are now available for 22 of the 23 AEDs available in Norway. The exception

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2018 Drug design, development and therapy

146. Cannabidiol for Drug Resistant Pediatric Epilepsy (Expanded Access Use)

, Eslicarbazepine Acetate, Ethosuximide, Felbamate, Gabapentin, Lacosamide, Lamotrigine, Levetiracetam, Lorazepam, Oxcarbazepine, Perampanel, Phenobarbital, Phenytoin, Pregabalin, Rufinamide, Valproic Acid, Vigabatrin, Zonisamide. Documentation must include the diagnosis of epilepsy type or epilepsy syndrome (if possible), as well as the underlying case, when known. Between 1-3 baseline anti-epileptic drugs at stable doses for a minimum of 4 weeks prior to enrollment. Vagus nerve stimulator, and dietary

2018 Clinical Trials

147. Recurrent epileptiform discharges in the medial entorhinal cortex of kainate-treated rats are differentially sensitive to antiseizure drugs. (PubMed)

-7-nitroquinoxaline-2,3-dione, (2R)-amino-5-phosphonovaleric acid, tetrodotoxin, or ASDs were bath applied for 20 minutes. Concentration-dependent effects and half maximal effective concentration values were determined for RED duration, frequency, and amplitude.ASDs targeting sodium and potassium channels (carbamazepine, eslicarbazepine, ezogabine, lamotrigine, lacosamide, phenytoin, and rufinamide) attenuated REDs at concentrations near their average therapeutic plasma concentrations. γ

2018 Epilepsia

148. Practice guideline update summary: Efficacy and tolerability of the new antiepileptic drugs I: Treatment of new-onset epilepsy: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and th (PubMed)

-quality studies suggest clobazam, eslicarbazepine, ezogabine, felbamate, GBP, lacosamide, LEV, LTG, oxcarbazepine, perampanel, pregabalin, rufinamide, tiagabine, topiramate, vigabatrin, or ZNS is effective in treating new-onset epilepsy because no high-quality studies exist in adults of various ages. A recent Food and Drug Administration (FDA) strategy allows extrapolation of efficacy across populations; therefore, for focal epilepsy, eslicarbazepine and lacosamide (oral only for pediatric use) as add

2018 Neurology

149. Practice guideline update summary: Efficacy and tolerability of the new antiepileptic drugs II: Treatment-resistant epilepsy: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the (PubMed)

(Level B): lacosamide, eslicarbazepine, and extended-release topiramate for TRAFE (ezogabine production discontinued); immediate- and extended-release lamotrigine for generalized epilepsy with TR generalized tonic-clonic (GTC) seizures in adults; levetiracetam (add-on therapy) for TR childhood focal epilepsy (TRCFE) (1 month-16 years), TR GTC seizures, and TR juvenile myoclonic epilepsy; clobazam for LGS (add-on therapy); zonisamide for TRCFE (6-17 years); oxcarbazepine for TRCFE (1 month-4 years (...) ). The text presents Level C recommendations. AED selection depends on seizure/syndrome type, patient age, concomitant medications, and AED tolerability, safety, and efficacy. This evidence-based assessment informs AED prescription guidelines for TR epilepsy and indicates seizure types and syndromes needing more evidence. A recent Food and Drug Administration (FDA) strategy allows extrapolation of efficacy across populations; therefore, for focal epilepsy, eslicarbazepine and lacosamide (oral only

2018 Neurology

150. Brivaracetam - Benefit assessment

of the following drugs: eslicarbazepine or gabapentin or lacosamide or lamotrigine or levetiracetam or oxcarbazepine or pregabalin or topiramate or valproic acid or zonisamide a: Presentation of the appropriate comparator therapy specified by the G-BA. G-BA: Federal Joint Committee The company claimed to have followed the G-BA regarding the ACT, but limited its assessment to a comparison with 2 of the drugs specified by the G-BA (lacosamide and eslicarbazepine). This approach was not followed because all drugs (...) specified by the G-BA are an option for a comprehensive individual antiepileptic adjunctive treatment. Irrespective of this, it was investigated whether, in the studies presented by the company, lacosamide or eslicarbazepine constituted the individually optimized treatment for the patients included in these studies. The assessment was conducted based on patient-relevant outcomes and on the data provided by the company in the dossier. Studies with a minimum duration of the maintenance phase of 12 weeks

2016 Institute for Quality and Efficiency in Healthcare (IQWiG)

151. 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

152. Antiepileptic drugs: updated advice on switching between different manufacturers? products

For these drugs, there are clear indications that clinically relevant differences between different manufacturers’ products might occur, even when the pharmaceutical forms are the same and bioequivalence has been shown Ensure that the patient is maintained on a specific manufacturer’s product. Category 2 Clobazam, Clonazepam, Eslicarbazepine, Lamotrigine, Oxcarbazepine, Perampanel, Retigabine, Rufinamide, Topiramate, Valproate, Zonisamide Drugs that do not fit into Category 1 or 3 Base the need for continued

2017 MHRA Drug Safety Update

153. Efficacy and safety of antiepileptic drugs for refractory partial-onset epilepsy: a network meta-analysis. (PubMed)

RCTs with 17 AEDs and 20,711 patients were included in the NMAs, which showed that Brivaracetam (BRV), Levetiracetam (LEV), Oxcarbazepine (OXC), Topiramate, Vigabatrin (VGB), and Valproate (VPA) had a greater likelihood of allowing patients to achieve seizure freedom. We also found that LEV was associated with a lower withdrawal rate due to adverse effects than Lacosamide, Eslicarbazepine acetate, OXC, Pregabalin, and Retigabine. LEV, VGB, VPA, and BRV emerged as the agents with the best

2017 Journal of neurology

154. 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

155. Efficacy and Tolerability of Second and Third Generation Anti-epileptic Drugs in Refractory Epilepsy: A Network Meta-Analysis. (PubMed)

obtained using a consistency model and surface under the cumulative ranking curve (SUCRA) value was calculated to rank AEDs. Topiramate appeared to be significantly more effective than placebo, eslicarbazepine acetate, perampanel, pregabalin, zonisamide, gabapentin and lamotrigine with respect to the 50% RR (all OR > 1). Patients who were managed by eslicarbazepine acetate, perampanel, oxcarbazepine, topiramate and pregabalin were more likely to suffer from dizziness compared to those who receive

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2017 Scientific reports

156. 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

157. 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

2017 European journal of clinical pharmacology

158. 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

159. 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

160. 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

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