Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 40 and up

Mirogabalin versus pregabalin for diabetic peripheral nerve pain

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

Run by Bangladesh Medical University · NCT07451431 · Data updated 2026-11-12

The trial tests whether mirogabalin works better or causes fewer side effects than pregabalin in adults with diabetic peripheral neuropathic pain.

Quick facts

PhasePhase 4
Study typeInterventional
Ages40 Years and up
SexAll
Enrollment78 (estimated)
SponsorBangladesh Medical University
Academic / other
Locations1 site (Dhaka)
StatusRecruiting
StartedOctober 1, 2025
Main results expectedMarch 2027
Study endsMay 2027
Registry record updatedMarch 9, 2026
Trial IDNCT07451431 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 40 or older with diabetic peripheral neuropathic pain, a Toronto neuropathy score ≥6, persistent symptoms despite standard therapy, and stable diabetes control (HbA1c ≤8.5%) are the ideal candidates.

Probably not a fit

Patients with cancer-related pain, entrapment radiculopathy, current opioid or other neuropathic pain medication use, pregnancy or lactation, or known gabapentinoid allergy are unlikely to benefit or be eligible.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with diabetic peripheral neuropathic pain (age ≥40 and Toronto neuropathy score ≥6) will be assigned to take either mirogabalin or pregabalin daily for eight weeks with clinic visits at weeks 1, 2, 4, 6, and 8. Pain intensity, safety events, and patient-reported quality-of-life measures will be recorded throughout the treatment period. Key eligibility requires persistent neuropathic pain despite standard therapy and stable diabetes control (HbA1c ≤8.5%), while patients on opioids or with gabapentinoid allergy, pregnancy, cancer pain, or radiculopathy are excluded. The trial compares efficacy and tolerability head-to-head to determine differences in analgesia and central nervous system side effects.

Why it matters

Potential benefit: If successful, mirogabalin could offer similar or better pain relief with fewer central nervous system side effects, improving daily function and quality of life.

How similar studies have gone: Phase III trials, primarily in Asian populations, have shown mirogabalin produces pain reduction comparable to pregabalin with fewer CNS side effects.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Bangladesh Medical University
    Dhaka, Bangladesh
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.