A multicenter trial of oxcarbazepine oral suspension monotherapy in children newly diagnosed with partial seizures: A clinical and cognitive evaluation

Kim, Heung Dong; Chung, Hee Jung; Kang, Hoon Chul; Lee, Joon Soo; Kim, Joon Sik; You, Su Jeong; Moon, Han Ku; Lee, Young Mock; Kim, Dong Wook; Suh, Eun Sook; Kim, Ji Yeon; Lee, Jun-Young; Eun, Baik Lin

doi:10.1016/j.seizure.2012.07.007

Cited by 18 publications

(6 citation statements)

References 16 publications

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“…Regarding the efficacy of the two ASMs, the seizure-free rates in the OXC and LEV groups in our study were relatively higher than those in previous trials, [18][19][20][21] which was probably due to our design bias and shorter follow-up time. Unlike other studies that recruited patients with drug-resistant epilepsy, 22 most hospitals participating in our study were primary hospitals where the majority of patients had epilepsy that was mild or moderate with low frequency of seizures, where intractable epilepsy and complications were relatively rare, resulting in a higher seizure-free rate.…”

Section: Discussioncontrasting

confidence: 77%

Efficacy comparison of oxcarbazepine and levetiracetam monotherapy among patients with newly diagnosed focal epilepsy in China: A multicenter, open‐label, randomized study

et al. 2022

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Aims This multicenter, open‐label, randomized study (Registration No. ChiCTR‐OCH‐14004528) aimed to compare the efficacy and effects of oxcarbazepine (OXC) with levetiracetam (LEV) as monotherapies on patient quality of life and mental health for patients with newly diagnosed focal epilepsy from China. Methods Patients with newly diagnosed focal epilepsy who had experienced 2 or more unprovoked seizures at greater than a 24‐h interval during the previous year were recruited. Participants were randomly assigned to the OXC group or LEV group. Efficacy, safety, quality of life, and mental health were evaluated over 12‐week and 24‐week periods. Results In total, we recruited 271 newly diagnosed patients from 23 centers. Forty‐four patients were excluded before treatment for reasons. The rate of seizure freedom of OXC was significantly superior to that of LEV at 12 weeks and 24 weeks (p < 0.05). The quality of life (except for the seizure worry subsection) and anxiety scale scores also showed significant differences from before to after treatment in the OXC and LEV groups. Conclusions OXC monotherapy may be more effective than LEV monotherapy in patients with newly diagnosed focal epilepsy. Both OXC and LEV could improve the quality of life and anxiety state in adult patients with focal epilepsy.

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Section: Discussioncontrasting

confidence: 77%

Efficacy comparison of oxcarbazepine and levetiracetam monotherapy among patients with newly diagnosed focal epilepsy in China: A multicenter, open‐label, randomized study

et al. 2022

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“…On the basis of these findings, we can infer that OXC medication should be prescribed to patients with pediatric epilepsy without concern about possible linguistic problems. Eun et al 39 drew similar conclusions, asserting that OXC is an effective anticonvulsant for both adults and children and is safe to use without inducing verbal or cognitive adverse effects.…”

Section: Discussionmentioning

confidence: 83%

“…However, most of these studies were limited to a small number of adult patients. 35 36 37 38 Conversely, studies that included pediatric patients found that OXC had no negative influence on cognitive function, 7 39 and there is a lack of evidence regarding the effects of OXC on linguistic ability. The present study successfully established that OXC treatment does not promote any remarkable adverse effects but rather enhances the pragmatic and discourse aspects, which are crucial in language use.…”

Section: Discussionmentioning

confidence: 99%

Effect of Oxcarbazepine on Language Function in Patients With Newly Diagnosed Pediatric Epilepsy

2023

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Background and Purpose This study aimed to determine the effects of oxcarbazepine (OXC) on the language function of patients with pediatric epilepsy. Methods We assessed the language abilities of patients aged 5–17 years with newly diagnosed focal epilepsy and the same number of age-matched healthy children using the Test of Problem Solving (TOPS) and the Receptive and Expressive Vocabulary Test–Receptive (REVT-R). The Mean Length of Utterance–words (MLU-w) was used to estimate linguistic productivity before and after OXC initiation. All patients received OXC monotherapy with a starting dosage of 10 mg/kg/day for 1 week, which in some cases was increased to 30 mg/kg/day (or 1,200 mg/day). Results The study finally included 41 pediatric patients (22 males and 19 females; age 9.9±3.0 years, mean±standard deviation). All language parameters of the TOPS improved significantly after initiating OXC (determining cause, 12.5±4.8–13.7±4.1 [ p =0.016]; making inference, 15.6±5.6–17.4±6.4 [ p <0.001]; and predicting, 9.8±5.0–11.6±4.5 [ p =0.001]). However, patients who received OXC did not exhibit a significantly extended MLU-w (determining cause, p =0.493; making inference, p =0.386; and predicting, p =0.341). Receptive language scores also significantly increased after taking OXC (REVT-R: 121.0±43.1–129.4±43.8, p =0.002), but the percentage of development age to chronological age did not vary (REVT-developmental quotient: p =0.075). Conclusions Our results suggest that OXC is safe and preserves language function in patients with pediatric epilepsy.

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“…The approved label mentioned explicitly that "pharmacokinetic/pharmacodynamic (PK/ PD) modeling provided confirmatory evidence of efficacy across all doses." The anti-epileptic oxcarbazepine (Trileptal) was approved as monotherapy in children, based on advanced PK/PD modeling [41] and subsequently confirmed in a clinical trial [42].…”

Section: Other Examples Of Modeling Influencing Regulatory Decisionsmentioning

confidence: 99%

Big data to smart data in Alzheimer's disease: Real‐world examples of advanced modeling and simulation

Haas¹,

Stephenson

Romero

et al. 2016

Alzheimer's & Dementia

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Many disease-modifying clinical development programs in Alzheimer's disease (AD) have failed to date, and development of new and advanced preclinical models that generate actionable knowledge is desperately needed. This review reports on computer-based modeling and simulation approach as a powerful tool in AD research. Statistical data-analysis techniques can identify associations between certain data and phenotypes, such as diagnosis or disease progression. Other approaches integrate domain expertise in a formalized mathematical way to understand how specific components of pathology integrate into complex brain networks. Private-public partnerships focused on data sharing, causal inference and pathway-based analysis, crowdsourcing, and mechanism-based quantitative systems modeling represent successful real-world modeling examples with substantial impact on CNS diseases. Similar to other disease indications, successful real-world examples of advanced simulation can generate actionable support of drug discovery and development in AD, illustrating the value that can be generated for different stakeholders.

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A multicenter trial of oxcarbazepine oral suspension monotherapy in children newly diagnosed with partial seizures: A clinical and cognitive evaluation

Abstract: OXC is effective and well-tolerated as monotherapy in children with partial seizures. There was no difference in the effectiveness of OXC between intellectually normal and intellectually impaired children.

Cited by 18 publications

References 16 publications

Efficacy comparison of oxcarbazepine and levetiracetam monotherapy among patients with newly diagnosed focal epilepsy in China: A multicenter, open‐label, randomized study

Efficacy comparison of oxcarbazepine and levetiracetam monotherapy among patients with newly diagnosed focal epilepsy in China: A multicenter, open‐label, randomized study

Effect of Oxcarbazepine on Language Function in Patients With Newly Diagnosed Pediatric Epilepsy

Big data to smart data in Alzheimer's disease: Real‐world examples of advanced modeling and simulation

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