RecruitingPhase 4NCT07451431

Efficacy and Safety of Mirogabalin in Diabetic Peripheral Neuropathic Pain

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


Sponsor

Bangladesh Medical University

Enrollment

78 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 40 Years

Inclusion Criteria3

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

Exclusion Criteria5

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

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Interventions

DRUGMirogabalin

Mirogabalin in diabetic peripheral neuropathic pain

DRUGPregabalin

Pregabalin in diabetic peripheral neuropathic pain


Locations(1)

Bangladesh Medical University

Dhaka, Bangladesh

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NCT07451431