Mirogabalin versus pregabalin for diabetic peripheral nerve pain
Efficacy, Safety and Patient-Reported Outcomes of Mirogabalin in Diabetic Peripheral Neuropathic Pain
PHASE4 · Bangladesh Medical University · NCT07451431
The trial tests whether mirogabalin works better or causes fewer side effects than pregabalin in adults with diabetic peripheral neuropathic pain.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 78 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Bangladesh Medical University (other) |
| Locations | 1 site (Dhaka) |
| Trial ID | NCT07451431 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Phase III trials, primarily in Asian populations, have shown mirogabalin produces pain reduction comparable to pregabalin with fewer CNS side effects.
Eligibility criteria
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 this trial is running
Dhaka
- Bangladesh Medical University — Dhaka, Bangladesh (RECRUITING)
Study contacts
- Study coordinator: Kazi Mahzabin Arin, MD
- Email: kazimahzabinarin@bsmmu.edu.bd
- Phone: +8801754057689
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetic Peripheral Neuropathic Pain, Mirogabalin, Safety, Efficacy