Efficacy and Safety of Mirogabalin in Diabetic Peripheral Neuropathic Pain

NCT07451431 | Recruiting Phase 4 DMC

• 1 other identifier: #5739
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Peripheral Neuropathic Pain (DPNP)

Keywords

Mirogabalin; Diabetic Peripheral Neuropathic Pain; Safety; Efficacy

Outcome Measures

Primary Outcomes (1)

• Neuropathic Pain Scale (NPS) score

  Change in neuropathic pain intensity measured using the Neuropathic Pain Scale (NPS). Scores range from 0 to 100, with higher scores indicating more severe pain.

  baseline, 4 weeks, and 8 weeks

Secondary Outcomes (2)

• frequency and severity of adverse events

  Week 1, 2, 4, 6, and 8

• Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) score

  Weeks 1, 2, 4, 6, and 8

Study Arms (2)

Group P

ACTIVE COMPARATOR

Pregabalin for diabetic peripheral neuropathic pain

Drug: Pregabalin

Group M

EXPERIMENTAL

Mirogabalin in Neuropathic Pain

Drug: Mirogabalin

Interventions

Mirogabalin DRUG

Mirogabalin in diabetic peripheral neuropathic pain

Group M

Pregabalin DRUG

Pregabalin in diabetic peripheral neuropathic pain

Group P

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Bangladesh Medical University

Dhaka, 1000, Bangladesh

RECRUITING

Related Publications (17)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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: 10.1155/2014/754693.

  PMID: 25479151 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Russell JW, Zilliox LA. Diabetic neuropathies. Continuum (Minneap Minn). 2014 Oct;20(5 Peripheral Nervous System Disorders):1226-40. doi: 10.1212/01.CON.0000455884.29545.d2.

  PMID: 25299279 BACKGROUND

• Tesfaye S, Vileikyte L, Rayman G, Sindrup SH, Perkins BA, Baconja M, Vinik AI, Boulton AJ; Toronto Expert Panel on Diabetic Neuropathy. Painful diabetic peripheral neuropathy: consensus recommendations on diagnosis, assessment and management. Diabetes Metab Res Rev. 2011 Oct;27(7):629-38. doi: 10.1002/dmrr.1225.

  PMID: 21695762 BACKGROUND

• Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.

  PMID: 27999003 BACKGROUND

• Greig M, Tesfaye S, Selvarajah D, Wilkinson ID. Insights into the pathogenesis and treatment of painful diabetic neuropathy. Handb Clin Neurol. 2014;126:559-78. doi: 10.1016/B978-0-444-53480-4.00037-0.

  PMID: 25410244 BACKGROUND

• Boulton AJ, Vinik AI, Arezzo JC, Bril V, Feldman EL, Freeman R, Malik RA, Maser RE, Sosenko JM, Ziegler D; American Diabetes Association. Diabetic neuropathies: a statement by the American Diabetes Association. Diabetes Care. 2005 Apr;28(4):956-62. doi: 10.2337/diacare.28.4.956. No abstract available.

  PMID: 15793206 BACKGROUND

• Baron R, Treede RD, Birklein F, Cegla T, Freynhagen R, Heskamp ML, Kern KU, Maier C, Rolke R, Seddigh S, Sommer C, Stander S, Maihofner C. Treatment of painful radiculopathies with capsaicin 8% cutaneous patch. Curr Med Res Opin. 2017 Aug;33(8):1401-1411. doi: 10.1080/03007995.2017.1322569. Epub 2017 May 4.

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• Baba M, Matsui N, Kuroha M, Wasaki Y, Ohwada S. Mirogabalin for the treatment of diabetic peripheral neuropathic pain: A randomized, double-blind, placebo-controlled phase III study in Asian patients. J Diabetes Investig. 2019 Sep;10(5):1299-1306. doi: 10.1111/jdi.13013. Epub 2019 Feb 28.

  PMID: 30672128 BACKGROUND

• Attal N, Cruccu G, Haanpaa M, Hansson P, Jensen TS, Nurmikko T, Sampaio C, Sindrup S, Wiffen P; EFNS Task Force. EFNS guidelines on pharmacological treatment of neuropathic pain. Eur J Neurol. 2006 Nov;13(11):1153-69. doi: 10.1111/j.1468-1331.2006.01511.x.

  PMID: 17038030 BACKGROUND

• Anandhanarayanan A, Teh K, Goonoo M, Tesfaye S, Selvarajah D. Diabetic Neuropathies. 2022 Mar 15. In: Feingold KR, Adler RA, Ahmed SF, Anawalt B, Blackman MR, Chrousos G, Corpas E, de Herder WW, Dhatariya K, Dungan K, Hamilton E, Hofland J, Jan de Beur S, Kalra S, Kaltsas G, Kapoor N, Kim M, Koch C, Kopp P, Korbonits M, Kovacs CS, Kuohung W, Laferrere B, Levy M, McGee EA, McLachlan R, Muzumdar R, Purnell J, Rey R, Sahay R, Shah AS, Sperling MA, Stratakis CA, Trence DL, Wilson DP, editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000-. Available from http://www.ncbi.nlm.nih.gov/books/NBK279175/

  PMID: 25905398 BACKGROUND

MeSH Terms

Interventions

mirogabalin; Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• AKM Akhtaruzzaman, MD

  Bangladesh Medical University

  STUDY DIRECTOR

Central Study Contacts

Kazi Mahzabin Arin, MD

CONTACT

+8801754057689; kazimahzabinarin@bsmmu.edu.bd

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anaesthesia, Analgesia and Intensive Care Medicine

Study Record Dates

• First Submitted: February 28, 2026
• First Posted: March 5, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)