Efficacy and Safety of Mirogabalin in Diabetic Peripheral Neuropathic Pain

Официальное название

Efficacy, Safety and Patient-Reported Outcomes of Mirogabalin in Diabetic Peripheral Neuropathic Pain

Обзор

The goal of this clinical trial is to learn if drug Mirogabalin works to treat diabetic peripheral neuropathic pain in adults. It will also learn about the safety of the drug Mirogabalin. The main questions it aims to answer are: Does drug mirogabalin reduce neuropathic pain intensity? Is the drug mirogabalin safe in patients with diabetes suffering from neuropathic pain? Does drug mirogabalin improve patients' quality of life (QoL) ( physical, mental, and social well-being)? Researchers will compare drug mirogabalin to drug pregabalin (a drug conventionally used to treat diabetic neuropathic pain) to see if drug mirogabalin works to treat, safe and improve quality of life (QoL) in diabetic neuropathic pain. Participants will: Take drug Mirogabalin or pregabalin every day for 8 weeks Visit the clinic at 1, 2, 4, 6, 8 weeks for checkups

Подробное описание

Diabetic Peripheral Neuropathic Pain (DPNP) is pain arising from abnormalities of the somatosensory system due to diabetes. It commonly manifests as burning or shooting pain, allodynia, and hyperalgesia, which interfere with sleep, mood, and daily activities. Pathophysiology involves hyperglycemia-induced nerve injury, sodium channel dysregulation, and central sensitization, resulting in complex pain states often resistant to standard analgesics.

Current first-line therapies for DPNP include pregabalin, duloxetine, and gabapentin. However, fewer than 50% of patients achieve adequate pain relief, and adverse effects such as somnolence and dizziness contribute to high discontinuation rates. Second- and third-line treatments, including tramadol, tapentadol, topical capsaicin, or lidocaine infusion, provide limited relief and are associated with safety or tolerability concerns.

Mirogabalin, a selective α₂δ-1 ligand, offers a potential improvement in the management of DPNP by targeting pain pathways while reducing CNS adverse effects. Its high-affinity binding to the α₂δ-1 subunit of voltage-gated calcium channels prolongs analgesia, while reduced activity at the α₂δ-2 subunit mitigates somnolence and dizziness. Phase III studies in Asian populations indicate comparable pain reduction to pregabalin, with fewer CNS side effects.

This study aims to evaluate and compare the efficacy, safety, and patient-reported outcomes of mirogabalin and pregabalin in patients with DPNP. The trial will provide robust data on pain reduction, adverse events, quality of life, and treatment satisfaction to guide optimal therapeutic strategies.

Вмешательства

• Препарат Mirogabalin
  Mirogabalin in diabetic peripheral neuropathic pain
• Препарат Pregabalin
  Pregabalin in diabetic peripheral neuropathic pain

Первичные конечные точки

• Neuropathic Pain Scale (NPS) score [Срок оценки: baseline, 4 weeks, and 8 weeks]

Вторичные конечные точки (2)

• frequency and severity of adverse events [Срок оценки: Week 1, 2, 4, 6, and 8]
• Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) score [Срок оценки: Weeks 1, 2, 4, 6, and 8]

Критерии участия

Критерии включения

• Adults (≥40 years) with diabetic neuropathy (Toronto score ≥6).
• Persistent pain (NPS) despite standard therapy.
• Stable diabetes management (HbA1c ≤8.5%).

Критерии исключения

• History of drug allergy to gabapentinoids.
• Concurrent use of opioids or other neuropathic pain medications.
• Pregnancy or lactation.
• Cancer pain
• Entraptment Radioculopathy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Bangladesh · 1 центр

• Bangladesh Medical University — Dhaka

Публикации

• Alyoubi RA, Alshareef AA, Aldughaither SM, Aljaroudi AM, Alabdulwahed A, Alduraibi FM, Masoud AT, Abu-Zaid A. Efficacy and safety of mirogabalin treatment in patients with diabetic peripheral neuropathic pain: A systematic review and meta-analysis of randomised controlled trials. Int J Clin Pract. 2021 May;75(5):e13744. doi: 10.1111/ijcp.13744. Epub 2020 Oct 27. PMID 32991782
• Domon Y, Arakawa N, Inoue T, Matsuda F, Takahashi M, Yamamura N, Kai K, Kitano Y. Binding Characteristics and Analgesic Effects of Mirogabalin, a Novel Ligand for the alpha2delta Subunit of Voltage-Gated Calcium Channels. J Pharmacol Exp Ther. 2018 Jun;365(3):573-582. doi: 10.1124/jpet.117.247551. Epub 2018 Mar 21. PMID 29563324
• Javed S, Alam U, Malik RA. Mirogabalin and emerging therapies for diabetic neuropathy. J Pain Res. 2018 Aug 22;11:1559-1566. doi: 10.2147/JPR.S145999. eCollection 2018. PMID 30174455
• Kato J, Baba M, Kuroha M, Kakehi Y, Murayama E, Wasaki Y, Ohwada S. Safety and Efficacy of Mirogabalin for Peripheral Neuropathic Pain: Pooled Analysis of Two Pivotal Phase III Studies. Clin Ther. 2021 May;43(5):822-835.e16. doi: 10.1016/j.clinthera.2021.03.015. Epub 2021 May 29. PMID 34059327
• Moulin D, Boulanger A, Clark AJ, Clarke H, Dao T, Finley GA, Furlan A, Gilron I, Gordon A, Morley-Forster PK, Sessle BJ, Squire P, Stinson J, Taenzer P, Velly A, Ware MA, Weinberg EL, Williamson OD; Canadian Pain Society. Pharmacological management of chronic neuropathic pain: revised consensus statement from the Canadian Pain Society. Pain Res Manag. 2014 Nov-Dec;19(6):328-35. doi: 10.1155/2014/7 PMID 25479151
• Zajaczkowska R, Mika J, Leppert W, Kocot-Kepska M, Malec-Milewska M, Wordliczek J. Mirogabalin-A Novel Selective Ligand for the alpha2delta Calcium Channel Subunit. Pharmaceuticals (Basel). 2021 Jan 31;14(2):112. doi: 10.3390/ph14020112. PMID 33572689
• Li Z, Taylor CP, Weber M, Piechan J, Prior F, Bian F, Cui M, Hoffman D, Donevan S. Pregabalin is a potent and selective ligand for alpha(2)delta-1 and alpha(2)delta-2 calcium channel subunits. Eur J Pharmacol. 2011 Sep 30;667(1-3):80-90. doi: 10.1016/j.ejphar.2011.05.054. Epub 2011 Jun 1. PMID 21651903
• Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, Gilron I, Haanpaa M, Hansson P, Jensen TS, Kamerman PR, Lund K, Moore A, Raja SN, Rice AS, Rowbotham M, Sena E, Siddall P, Smith BH, Wallace M. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015 Feb;14(2):162-73. doi: 10.1016/S1474-4422(14)70251-0. Epub 2015 Jan 7. PMID 25575710

Идентификаторы

NCT: NCT07451431 · #5739

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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