Efficacy and Safety of Mirogabalin in Diabetic Peripheral Neuropathic Pain

March 6, 2026 updated by: Kazi Mahzabin Arin, Bangladesh Medical University

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.

Participants will:

Take drug Mirogabalin or pregabalin every day for 8 weeks Visit the clinic at 1, 2, 4, 6, 8 weeks for checkups

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1000
        • Recruiting
        • Bangladesh Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ananna Mallik, MD Resident

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group P
Pregabalin for diabetic peripheral neuropathic pain
Drug: Pregabalin
Pregabalin in diabetic peripheral neuropathic pain
Experimental: Group M
Mirogabalin in Neuropathic Pain
Drug: Mirogabalin
Mirogabalin in diabetic peripheral neuropathic pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropathic Pain Scale (NPS) score
Time Frame: baseline, 4 weeks, and 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequency and severity of adverse events
Time Frame: Week 1, 2, 4, 6, and 8
Safety and tolerability, assessed by the frequency and severity of adverse events documented systematically using CTCAE v5.0 criteria
Week 1, 2, 4, 6, and 8
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) score
Time Frame: Weeks 1, 2, 4, 6, and 8
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.
Weeks 1, 2, 4, 6, and 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangladesh Medical University

Investigators

  • Study Director: AKM Akhtaruzzaman, MD, Bangladesh Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

February 28, 2026

First Submitted That Met QC Criteria

February 28, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #5739

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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