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
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 78 (estimated) |
| Sponsor | Bangladesh Medical University Academic / other |
| Locations | 1 site (Dhaka) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | March 2027 |
| Study ends | May 2027 |
| Registry record updated | March 9, 2026 |
| Trial ID | NCT07451431 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
- Study coordinator: Kazi Mahzabin Arin, MD
- Email: kazimahzabinarin@bsmmu.edu.bd
- Phone: +8801754057689
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.