Diabetic Peripheral Neuropathic Pain (DPNP)Phase 4NCT07451431
Efficacy and Safety of Mirogabalin in Diabetic Peripheral Neuropathic Pain
A Phase 4 study testing Mirogabalin and Pregabalin in people with Diabetic Peripheral Neuropathic Pain (DPNP), run by Bangladesh Medical University at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetic Peripheral Neuropathic Pain (DPNP)
- What is being tested?
- Mirogabalin and Pregabalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Oct 2025to May 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥40 years) with diabetic neuropathy (Toronto score ≥6).
- Persistent pain (NPS) despite standard therapy.
- Stable diabetes management (HbA1c ≤8.5%).
Who cannot join
- History of drug allergy to gabapentinoids.
- Concurrent use of opioids or other neuropathic pain medications.
- Pregnancy or lactation.
- Cancer pain
- Entraptment Radioculopathy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Bangladesh Medical University
Dhaka, 1000
AKM Mahzabin Akhtaruzzaman, MD, +8801819220195, akm.akhtaruzzaman@bmu.ac.bd
Kazi Mahzabin Arin, MD, +8801754057689, kazimahzabinarin@bsmmu.edu.bd
About this study
Official title: Efficacy, Safety and Patient-Reported Outcomes of Mirogabalin in Diabetic Peripheral Neuropathic Pain
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.
Read more
Participants will:
Take drug Mirogabalin or pregabalin every day for 8 weeks Visit the clinic at 1, 2, 4, 6, 8 weeks for checkups
Read the detailed description
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.
- Being tested
- Mirogabalin, Pregabalin
- Keywords
- Mirogabalin, Diabetic Peripheral Neuropathic Pain, Safety, Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirogabalinDrug
Mirogabalin in diabetic peripheral neuropathic pain
PregabalinDrug
Pregabalin in diabetic peripheral neuropathic pain
| Study group | Role | What they receive |
|---|---|---|
| Group P | Active comparator | Pregabalin for diabetic peripheral neuropathic pain Receives: Drug: Pregabalin |
| Group M | Experimental | Mirogabalin in Neuropathic Pain Receives: Drug: Mirogabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 4 weeks, and 8 weeks
Secondary outcomes (2)
frequency and severity of adverse events
Safety and tolerability, assessed by the frequency and severity of adverse events documented systematically using CTCAE v5.0 criteria
Measured: Week 1, 2, 4, 6, and 8
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) score
Change in neuropathic pain intensity measured using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS). Scores range from 0 to 24, with higher scores indicating more severe neuropathic pain.
Measured: Weeks 1, 2, 4, 6, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Oct 2025
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral Neuropathic Pain (DPNP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazi Mahzabin Arin, Bangladesh Medical University
- Investigators
- AKM Akhtaruzzaman, MD, Study director, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451431
- Sponsor's protocol ID
- #5739
- Status last verified
- Mar 2026
- First submitted
- 28 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32991782Domon 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.
PubMed 29563324Javed 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.
PubMed 30174455Kato 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.
PubMed 34059327Moulin 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.
PubMed 25479151Zajaczkowska 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.
PubMed 33572689Li 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.
PubMed 21651903Finnerup 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.
PubMed 25575710Russell 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.
PubMed 25299279Tesfaye 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.
PubMed 21695762Pop-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.
PubMed 27999003Greig 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.
PubMed 25410244Boulton 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.
PubMed 15793206Baron 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.
PubMed 28436279Baba 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.
PubMed 30672128