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Oxcarbazepine oral suspension in pediatric patients with partial seizures and/or generalized tonic-clonic seizures: a multi-center, single arm, observational study in China

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Abstract

Background

To assess efficacy and safety of oxcarbazepine (OXC) oral suspension in pediatric patients aged 2–16 years with partial seizures (PS) and/or generalized tonic-clonic seizures (GTCS) in real-world clinical practice in China.

Methods

This 26-week, single arm, multicenter and observational study recruited patients aged 2–16 years with PS or GTCS suitable for OXC oral suspension treatment. Enrolled patients received OXC oral suspension treatment for 26 weeks. Primary endpoints included mean seizure frequency at the end of the treatment and mean seizure frequency reduction at the end of the treatment vs. baseline. Secondary efficacy-related endpoints and safety parameters were also assessed.

Results

Nine hundred and eighty-seven pediatric patients were enrolled and 912 (92.4%) completed the study. The mean seizure frequencies at baseline and the end of week 26 were 13.40±64.92 and 1.62±19.47 times/ month, respectively. The mean seizure frequency reduction was 10.03±63.67 times/month and the mean seizure frequency reduction percentage was 90.02%±5127.0% (P<0.0001). After 26 weeks of treatment, 82.36%, 7.24% and 3.86% of the patients became controlled, significantly improved and improved, respectively. Adverse events (AEs) were reported in 74 (7.65%) patients. Rash was the most common AE. The efficacy of OXC was not affected by seizure types, age or gender.

Conclusions

This study confirms the efficacy and good safety profile of OXC oral suspension in Chinese pediatric patients aged 2–16 years with PS and/or GTCS.

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Acknowledgements

We would like to thank the following hospitals for their participation in and generous assistance for this study (the order of the hospitals does not ref lect their contributions): Children’s Hospital of Fudan University, Shanghai; The First Bethune Hospital of Jilin University; Tianjin Children’s Hospital; West China Second University Hospital of Sichuan University; Shengjing Hospital of China Medical University; Beijing Children’s Hospital, Capital Medical University; Xi’an Children’s Hospital; Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology; The 2nd Affiliated Hospital of Wenzhou Medical University; Peking University First Hospital; Tangshan Women and Children’s Hospital; Quanzhou Children’s Hospital; Yantai Yuhuangding Hospital; Huai’an Third People’s Hospital; Dalian Children’s Hospital of Dalian Medical University; Xiangya Hospital of Central South University; The Second Affiliated Hospital of Guangzhou Medical University; Chinese PLA General Hospital; Xijing Hospital, The Fourth Military Medical University; Shenzhen No.2 People’s Hospital; Beijing Handian Hospital; Affiliated Hospital of Tianjin Armed Police Medical College and Sanbo Brain Hospital of Capital Medical University. Medical writing support was provided by Xin Liu of Shanghai Zhiliao Data Systems Co., Ltd. Trial result synopsis, manuscript revision and compiling work was provided by Quan Hu, PhD, of Beijing Novartis Pharma Co., Ltd. All of the editorial support was funded by Beijing Novartis Pharma Co., Ltd.

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Authors and Affiliations

  1. Department of Neurology, Children’s Hospital of Fudan University, Shanghai, China

    Yi Wang

  2. Department of Pediatric Neurology, The First Bethune Hospital of Jilin University, Changchun, China

    Yin-Bo Chen

  3. Department of Neurology, Tianjin Children’s Hospital, Tianjin, China

    Yu-Qin Zhang

  4. Department of Pediatric Neurology, West China Second University Hospital of Sichuan University, Chengdu, China

    Rong Luo

  5. Department of Pediatric Neurology, Shengjing Hospital of China Medical University, Shenyang, China

    Hua Wang

  6. Department of Neurology, Beijing Children’s Hospital, Capital Medical University, Beijing, China

    Jun-Lan Lv

  7. Department of Neurology, Xi’an Children’s Hospital, Xi’an, China

    Dong Wang

  8. Department of Neurology, Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology, Wuhan, China

    Sui-Qiang Zhu

  9. Department of Pediatric Neurology, The 2nd Affiliated Hospital of Wenzhou Medical University, Wenzhou, China

    Zhong-Dong Lin

  10. Department of Pediatrics, Peking University People’s Hospital, No.11 Xizhimen South Str., Xicheng District, Beijing, 100044, China

    Jiong Qin

  11. Department of Pediatrics, Peking University First Hospital, Beijing, China

    Jiong Qin

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  1. Yi Wang
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Correspondence to Jiong Qin.

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Wang, Y., Chen, YB., Zhang, YQ. et al. Oxcarbazepine oral suspension in pediatric patients with partial seizures and/or generalized tonic-clonic seizures: a multi-center, single arm, observational study in China. World J Pediatr 13, 551–559 (2017). https://doi.org/10.1007/s12519-017-0045-2

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  • DOI: https://doi.org/10.1007/s12519-017-0045-2

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