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. 2025 Jul 21.
doi: 10.1007/s00210-025-04474-4. Online ahead of print.

A comparison of the effectiveness of lacosamide and pregabalin in treating patients diagnosed with neuropathic pain: a randomized, controlled, open-label pilot trial

R Kalpana  1 , W S Robert  1 , Fatema Juzerehaji  2 , Ramesh Venkatachalapathy  2 , M Jagadeesan  3
Affiliations

A comparison of the effectiveness of lacosamide and pregabalin in treating patients diagnosed with neuropathic pain: a randomized, controlled, open-label pilot trial

R Kalpana et al. Naunyn Schmiedebergs Arch Pharmacol. .

Abstract

Chronic neuropathic pain is characterized by complex pathophysiology, and its treatment is associated with significant healthcare costs and resources. Controlling pain intensity remains challenging, necessitating alternative therapeutic approaches. Lacosamide and pregabalin have shown efficacy in neuropathic pain management, but comparative studies, particularly in the Indian population, are limited. A prospective, open-label, randomized controlled, parallel-arm pilot study was conducted on patients of either gender > 18 years of age with definite or probable neuropathic pain lasting beyond three months. Of 72 screened patients, 36 were randomized to receive either lacosamide (50 mg BD P/O for 1 week, then 100 mg BD P/O for 3 months) or pregabalin (75 mg OD P/O for 3 months). Analgesic efficacy was assessed using the Numeric Rating Scale (NRS), and quality of life was evaluated with the SF-36 Questionnaire. Adverse drug reactions (ADRs) were assessed using the Naranjo Algorithm. SPSS software version 16.0 was used for statistical analysis, with p-values < 0.05 considered significant. Of 72 screened patients, 36 were randomized, and 7 dropped out, leaving 15 in the pregabalin group and 14 in the lacosamide group. The mean age was 52 years, and the mean BMI was 24 kg/m2. Lacosamide significantly reduced pain (NRS: 7.7 to 2.50) compared to pregabalin (7.6 to 4.27) (p < 0.001), indicating greater effectiveness. Both drugs improved all SF-36 quality of life domains (p < 0.001), with no significant difference between groups in overall quality of life. Lacosamide therapy was more costly due to its twice-daily dosing. No serious ADRs were observed. Lacosamide is more effective than pregabalin in reducing chronic neuropathic pain and contributes to improved quality of life, comparable to pregabalin. Despite higher costs, lacosamide is safe and recommended for adults aged ≥ 18 years. Limitations include the open-label design, small sample size, lack of placebo control, and absence of neuropathic pain phenotype analysis, necessitating larger, double-blind trials to confirm findings.

Keywords: Analgesic efficacy; Chronic neuropathic pain; Lacosamide; Numeric Rating Scale (NRS); Pregabalin.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: A written consent form was obtained from the patient. Ethics has been obtained from the IRB. Content for publication: Not applicable. Clinical trial data: The trial was registered in the Clinical Trials registry of India on 13/03/2020. Trail registry number: CTRI/2020/03/023953. Competing interest: The authors declare no competing interests.

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