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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
Are there results?
Not yet: the study is under way

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.

Kazi Mahzabin Arin, MD contact

+8801754057689

kazimahzabinarin@bsmmu.edu.bd

Bangladesh1 site, 1 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

    Recruiting

Other trials in Bangladesh

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 groups in NCT07451431
Study groupRoleWhat they receive
Group PActive comparatorPregabalin for diabetic peripheral neuropathic pain
Receives: Drug: Pregabalin
Group MExperimentalMirogabalin in Neuropathic Pain
Receives: Drug: Mirogabalin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline, 4 weeks, and 8 weeks

Secondary outcomes (2)

  1. 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

  2. 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.

  1. First posted5 Mar 2026
  2. Study start1 Oct 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

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)
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 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.

    PubMed 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.

    PubMed 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.

    PubMed 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: 10.1155/2014/754693.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 25575710

  • 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.

    PubMed 25299279

  • 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.

    PubMed 21695762

  • 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.

    PubMed 27999003

  • 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.

    PubMed 25410244

  • 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.

    PubMed 15793206

  • 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.

    PubMed 28436279

  • 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.

    PubMed 30672128

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kazi Mahzabin Arin, MD (+8801754057689, kazimahzabinarin@bsmmu.edu.bd), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neuropathic Pain Scale (NPS) score (time frame: baseline, 4 weeks, and 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07451431, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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