Effects of adjunctive eslicarbazepine acetate on neurocognitive functioning in children with refractory focal-onset seizures

Jóźwiak, Sergiusz; Veggiotti, Pierangelo; Moreira, Joana; Gama, Helena; Rocha, F.; Soares‐da‐Silva, Patrício

doi:10.1016/j.yebeh.2018.01.029

Cited by 28 publications

(32 citation statements)

References 33 publications

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“…If patients tolerated 20 mg/kg/day, the dose was increased to 30 mg/kg/day (maximum dose: 1200 mg/day) for the 8‐week maintenance period. Dose reduction was allowed once, during either the titration period (from 20 to 10 mg/kg/day) or the maintenance period (from 30 to 20 mg/kg/day) …”

Section: Methodsmentioning

confidence: 99%

“…Eslicarbazepine acetate (ESL) is a once‐daily, oral AED for the treatment of focal (partial‐onset) seizures in patients aged 4 years and older in the USA . Double‐blind, fixed‐duration clinical trials of adjunctive ESL have demonstrated that ESL is an effective and well‐tolerated treatment for focal seizures in both adults and children . ESL is a dibenzazepine carboxamide derivative.…”

Section: Introductionmentioning

confidence: 99%

“…5 Double-blind, fixed-duration clinical trials of adjunctive ESL have demonstrated that ESL is an effective and well-tolerated treatment for focal seizures in both adults and children. [6][7][8][9][10][11] ESL is a dibenzazepine carboxamide derivative. Relatively high rates of rash have previously been observed with phenytoin and lamotrigine (LTG), and other dibenzazepine carboxamides such as carbamazepine (CBZ) and oxcarbazepine (OXC), 1,2,[12][13][14][15][16][17][18][19] and so it is relevant to examine to what extent allergic reactions also occur with ESL, and whether there may be any identifiable risk factors.…”

Section: Introductionmentioning

confidence: 99%

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Analysis of cutaneous allergic reactions in clinical trials of eslicarbazepine acetate

Rogin¹,

Resnick

Strom

et al. 2020

Acta Neurol Scand

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Objectives To evaluate cutaneous allergic reactions in clinical trials of adjunctive eslicarbazepine acetate (ESL) for focal seizures. Materials and methods Data were analyzed from three phase III randomized, double‐blind, placebo‐controlled studies of adjunctive ESL in adults (placebo, n = 426; ESL, n = 1021) and two randomized, double‐blind, placebo‐controlled studies (and open‐label extensions [OLEs]) of adjunctive ESL in children aged 4‐17 years (placebo, n = 160; ESL, n = 202; OLE, n = 337). Results Adult studies: Rash (ESL 1.9%, placebo 0.9%) and pruritus (ESL 1.2%, placebo 0.9%) were the most frequent rash‐related treatment‐emergent adverse events (TEAEs). Most rash‐related TEAEs were mild or moderate in severity. Incidence of rash increased with increasing ESL dose, but was not higher for patients who initiated treatment with higher ESL doses. Pediatric studies: Allergic dermatitis (ESL 3.0%, placebo 0) and rash (controlled studies: ESL 1.0%, placebo 1.3%; OLE periods: ESL ≤1.2%) were the most frequent rash‐related TEAEs. There was one case of DRESS in the ESL group. Most rash‐related TEAEs were mild or moderate in severity and judged as not related to treatment with ESL. Conclusions Serious skin rashes were rare during adult and pediatric clinical trials of ESL. Although the incidence of rash with ESL was low, it is important for patients/caregivers to be made aware of the potential signs and symptoms associated with serious skin rashes.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Analysis of cutaneous allergic reactions in clinical trials of eslicarbazepine acetate

Rogin¹,

Resnick

Strom

et al. 2020

Acta Neurol Scand

View full text Add to dashboard Cite

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“…Kamboj and Curran (26) found negative effects of lorazepam and scopolamine on anterograde recognition memory in a similar task using narrative content. Jóźwiak et al (27) reported negative effects of adjunctive eslicarbazepine on episodic memory in children based on word or picture recognition. However, these studies on the effects of antiepileptic drugs on episodic memory did not test episodic memory in its narrow definition of experiencedependent memory formation (17).…”

Section: Introductionmentioning

confidence: 99%

Effects of Antiepileptic Drug Tapering on Episodic Memory as Measured by Virtual Reality Tests

et al. 2020

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Antiepileptic drugs impair episodic memory in patients with epilepsy, but this effect has so far only been examined with tests that do not provide first-person experience-an aspect that is crucial for episodic memory. Virtual reality techniques facilitate the development of ecologically valid tests. In the present study, we measure the effect of antiepileptic drug changes in a within-subject design using a virtual reality test in order to provide direct evidence for effects of antiepileptic drugs on episodic memory. Among 106 recruited patients, 97 participated in a virtual reality test up to six times during a 4-day hospitalization, and 78 patients underwent changes in drug load during this period. There were six parallel versions of a virtual town test, with immediate recall and delayed recall after about 12 h. The test requires recall of elements, details, sequence of experience, and egocentric and allocentric spatial memory. We determined drug load by defined daily dose, and compared test performance at lowest antiepileptic drug load to highest antiepileptic drug load. Across the six towns, performance was lower in delayed compared to immediate recall. There was an overall effect of medication when comparing patients taking vs. not taking antiepileptic drugs and/or psychoactive drugs (p = 0.005). Furthermore, there was a within-subject effect of antiepileptic drug load (p = 0.01), indicating lower test performance at higher drug load. There was no effect of gender, daytime, circadian type, depression, seizures, lesions, and epilepsy. For patients with temporal lobe epilepsy, there was no effect of lateralization. The present study provides direct evidence for episodic memory impairment due to antiepileptic drugs, suggesting that a small change in drug load can matter. This study can serve as a proof of principle for the methodology, but a larger sample is needed to examine the differential effects of individual antiepileptic drugs.

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“…Analysen der Sicherheitsdaten zeigten keine neuen oder unerwarteten Befunde. Zudem zeigte ESL keine konsistent negativen Auswirkungen auf neurokognitive Funktionen wie Aufmerksamkeit, Informationsverarbeitung oder Gedächtnis [15,17]. Im Jahr 2017 erfolgte dann die Erweiterung der Zulassung als Monotherapie, basierend auf den Erkenntnissen einer doppelblinden, aktiv-kontrollierten randomisierten Phase-III-Studie, in der ESL im Vergleich zu retardiertem Carbamazepin (CBZ-CR) bei 815 Patienten mit neu diagnostizierten fokalen epileptischen Anfällen untersucht wurde.…”

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Effektivität von Eslicarbazepinacetat in 2 unterschiedlichen Kohorten von Patienten mit Epilepsie in der klinischen Praxis – Ergebnisse einer retrospektiven Datensammlung aus 2 Epilepsiezentren in Deutschland

Brandt

Holtkamp

May³

et al. 2019

Z. Epileptol.

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Effects of adjunctive eslicarbazepine acetate on neurocognitive functioning in children with refractory focal-onset seizures

Abstract: Overall ESL did not produce statistically significant effects on neurocognitive and behavioral functioning in patients with epilepsy aged 6 to 16years. Additionally, ESL was effective in reducing seizure frequency and was well-tolerated.

Cited by 28 publications

References 33 publications

Analysis of cutaneous allergic reactions in clinical trials of eslicarbazepine acetate

Analysis of cutaneous allergic reactions in clinical trials of eslicarbazepine acetate

Effects of Antiepileptic Drug Tapering on Episodic Memory as Measured by Virtual Reality Tests

Effektivität von Eslicarbazepinacetat in 2 unterschiedlichen Kohorten von Patienten mit Epilepsie in der klinischen Praxis – Ergebnisse einer retrospektiven Datensammlung aus 2 Epilepsiezentren in Deutschland

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