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Safety and efficacy of levetiracetam and carbamazepine monotherapy in the management of pediatric focal epilepsy: a randomized clinical trial

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Abstract

Due to the limited number of studies in children with focal epilepsy and the importance of choosing the most suitable drug to control seizures in children, the administration of the most effective medication with the most negligible adverse events is vital. This study aimed to evaluate the effectiveness and adverse events of carbamazepine vs. levetiracetam monotherapy in children with focal seizures. A monocentric, randomized, controlled, double-blind, parallel-group clinical trial was designed. This study was approved by the Iranian Registry of Clinical Trials (registration number: IRCT20170216032603N2) on June 19, 2020, and conducted at the neurology department of Imam Ali Hospital, Karaj, Iran, from February 2020 to March 2021. This study assessed 120 patients with recently diagnosed focal seizures aged 2 to 14. Patients were randomly divided into two groups, who received carbamazepine (CBZ) 15 to 20 mg/kg and levetiracetam (LEV) 20 to 40 mg/kg daily, respectively. Patients were evaluated for improvement and complications at weeks 4, 12, and 24. Out of 120 patients included in the study, six patients were excluded due to various complications of CBZ. The mean number of seizures at the end of the fourth, twelfth, and twenty-fourth weeks were 1.09 ± 0.75, 0.62 ± 0.27, and 0.39 ± 0.12 in the carbamazepine group and 1.11 ± 0.63, 0.52 ± 0.21, and 0.37 ± 0.11 in the LEV group, respectively (P > 0.05). Similarly, the number of seizure-free patients was 34, 44, and 48 in the CBZ group compared to 41, 50, and 54 in the LEV group, respectively (P > 0.05). On the other hand, the frequency of somnolence, dermatologic complications, and agitation was considerably higher in the CBZ group (P < 0.05). Although both medicines were equally effective in seizure control, CBZ was associated with considerably more adverse events and less patient compliance. Physicians should be aware of this difference to prevent unwanted consequences.

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Data availability

The datasets generated and analyzed during the current study are not publicly available; however, the data can be shared for research and authentication purposes upon reasonable request.

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Acknowledgements

We are grateful for the support of the pediatric neurology department and every patient and their parents for their collaboration. Alborz University of Medical Sciences, Karaj, Iran, supported this clinical trial.

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Authors and Affiliations

  1. Department of Pediatric Neurology, Faculty of Medicine, Imam Ali Hospital, Alborz University of Medical Sciences, Karaj, Iran

    Hadi Montazerlotfelahi

  2. Student Research Committee, Alborz University of Medical Sciences, Karaj, Iran

    Arsh Haj Mohamad Ebrahim Ketabforoush

  3. Non-Communicable Diseases Research Center, Alborz University of Medical Sciences, Karaj, Iran

    Marzieh Tavakol

  4. Department of Pediatric Neurology, Children’s Medical Center, Tehran University of Medical Sciences, Tehran, Iran

    Mahmoudreza Ashrafi

  5. Department of Oral and Maxillofacial, Faculty of Dentistry, Tehran Medical Sciences of Islamic Azad University, Tehran, Iran

    Mahdieh Dehghani

  6. Department of the Pediatrics, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran

    Keihan Mostafavi

  7. Student Research Committee, Arak University of Medical Sciences, Arak, Iran

    Shayan Mardi

  8. Department of the Pediatrics, Faculty of Medicine, Imam Ali Hospital, Alborz University of Medical Sciences, Vali-Asr St., Shora Ave, Karaj, Iran

    Sanaz Tajfirooz

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  1. Hadi Montazerlotfelahi
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Contributions

HM, AHMEK, and ST conceived the study and participated in study design, data collection, and data analysis. HM, AHMEK, and MT wrote the manuscript. MA, MD, and KM participated in data collection and data analysis. AHMEK, MT, MA, KM, and MD assisted with preparing the document and interpreting the results. All the authors have read and approved the final submitted manuscript. The authors declare that all data were generated in-house and that no paper mill was used.

Corresponding author

Correspondence to Sanaz Tajfirooz.

Ethics declarations

Ethics approval and consent to participate

The Ethics Committee of Alborz University of Medical Sciences approved this study (Approval ID: IR.ABZUMS.REC.1398.208). The Iranian Registry of Clinical Trials approved the trial by the registration number IRCT20170216032603N2 on June 19, 2020. Informed consent was obtained from the patient's parents.

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The authors declare no competing interests.

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Key points box

1) The efficacy of both carbamazepine and levetiracetam in controlling focal epilepsy in children is similar.

2) Compared to levetiracetam, the adverse events of treatment were significantly higher with carbamazepine in children.

3) Considering efficacy and adverse events, levetiracetam is a better choice for monotherapy in children with focal epilepsy.

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Montazerlotfelahi, H., Haj Mohamad Ebrahim Ketabforoush, A., Tavakol, M. et al. Safety and efficacy of levetiracetam and carbamazepine monotherapy in the management of pediatric focal epilepsy: a randomized clinical trial. Naunyn-Schmiedeberg's Arch Pharmacol 397, 5233–5240 (2024). https://doi.org/10.1007/s00210-024-02954-7

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  • DOI: https://doi.org/10.1007/s00210-024-02954-7

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