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Oxcarbazepine oral suspension in young pediatric patients with partial seizures and/or generalized tonic–clonic seizures in routine clinical practice in China: a prospective observational study

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Abstract

Background

This study aimed to assess efficacy and safety of oxcarbazepine (OXC) oral suspension in pediatric patients aged 2–5 years with partial seizures (PS) and/or generalized tonic–clonic seizures (GTCS) in real-world clinical practice in China.

Methods

This 26-week, prospective, single-arm, multicenter, observational study recruited pediatric patients aged 2–5 years with PS or GTCS suitable for OXC oral suspension treatment based on physicians’ judgments from 11 medical centers in China. Enrolled subjects started OXC oral suspension treatment as monotherapy or in combination with other antiepileptic drugs. Primary efficacy outcome was the percentage of pediatric subjects achieving ≥ 50% seizure frequency reduction at the end of the 26-week treatment. Secondary efficacy-related parameters and safety parameters such as adverse events (AEs) and serious AEs (SAEs) were also monitored during the 26-week treatment period.

Results

Six hundred and six pediatric patients were enrolled and 531 (87.6%) completed the study. After 26 weeks of treatment, 93.3% subjects achieved ≥ 50% seizure frequency reduction, and 81.8% achieved 100% seizure frequency reduction compared to baseline. Among different seizure types, OXC was effective in all subjects with simple PS and in > 90% of subject with other type of seizure present in the study. AEs were observed in 49 (8.1%) subjects. Only three subjects experienced SAE. Rash (n = 18, 2.97%) was the most common AE. Only 17 subjects discontinued due to AEs.

Conclusion

This study, reporting the real-world data, further confirms the efficacy and good safety profile of OXC oral suspension in Chinese pediatric patients aged 2–5 years with PS and/or GTCS.

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Acknowledgements

We would like to thank all of the participating hospitals for their participation in the study and their support. The authors also want to thank Quan Hu (formerly Novartis) for the preparation and subsequent editorial work of manuscript. All the editorial support was funded by Beijing Novartis Pharma Co., Ltd.

Funding

This study was funded by Beijing Novartis Pharma Co., Ltd.

Author information

Authors and Affiliations

  1. Department of Pediatrics, Peking University People’s Hospital, No. 11 Xi Zhi Men Nan Da Jie, Xicheng District, Beijing, 100044, China

    Jiong Qin

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

    Jiong Qin & Ye Wu

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

    Yi Wang

  4. Department of Pediatrics, Quanzhou Women’s and Children’s Hospital, Quanzhou, China

    Xin-Fang Huang

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

    Yu-Qin Zhang

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

    Fang Fang

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

    Yin-Bo Chen

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

    Zhong-Dong Lin

  9. Department of Neurology, Xijing Hospital, Xi’an, China

    Yan-Chun Deng

  10. Department of Pediatrics, Xiangya Hospital, Central South University, Changsha, China

    Fei Yin

  11. Department of Neurology, Children’s Hospital, Chongqing Medical University, Chongqing, China

    Li Jiang

  12. The third Department of Neurology, Guangdong 999 Brain Hospital, Guangzhou, China

    Xiang-Shu Hu

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  1. Jiong Qin
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Contributions

QJ and WY were the principal designers of the study; they contributed equally to this work. All of the contributing authors participated in the concept and design of the study. Additionally, every contributing author oversaw the study and was in charge of patients’ treatment and acquisition of the data in his/her own hospital. All contributing authors participated in the analysis and interpretation of the data. All contributing authors gave input as to how to draft the article and each author also revised it critically for important intellectual content. Finally, all authors gave final approval of the version to be published.

Corresponding author

Correspondence to Jiong Qin.

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Ethical approval

The study was approved by the Independent Ethics Committees or Institutional Review Board for each study center, and was conducted in accordance with the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use, Good Clinical Practice guidelines and the Declaration of Helsinki.

Conflict of interest

Beijing Novartis Pharma Co., Ltd. participated in study design and data interpretation in collaboration with the authors and also made the decision to submit this article for publication; however, it did not in any way interfere or affect patient treatments, nor did it participate in data collection and analysis and writing of this manuscript.

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Qin, J., Wang, Y., Huang, XF. et al. Oxcarbazepine oral suspension in young pediatric patients with partial seizures and/or generalized tonic–clonic seizures in routine clinical practice in China: a prospective observational study. World J Pediatr 14, 280–289 (2018). https://doi.org/10.1007/s12519-017-0114-6

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  • DOI: https://doi.org/10.1007/s12519-017-0114-6

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