Health TrialsbyHealthPanel

Efficacy and Safety of Mirogabalin in Diabetic Peripheral Neuropathic Pain

ConditionDiabetic Peripheral Neuropathic Pain (DPNP)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorBangladesh Medical University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (≥40 years) with diabetic neuropathy (Toronto score ≥6).

Persistent pain (NPS) despite standard therapy.

Stable diabetes management (HbA1c ≤8.5%).

Disqualifiers

History of drug allergy to gabapentinoids.

Concurrent use of opioids or other neuropathic pain medications.

Pregnancy or lactation.

Cancer pain

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mirogabalin

    Drug

    Mirogabalin in diabetic peripheral neuropathic pain

  • Pregabalin

    Drug

    Pregabalin in diabetic peripheral neuropathic pain

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: Group PActive comparator 1 intervention
Group B: Group MExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Neuropathic Pain Scale (NPS) score

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.

Time frame
baseline, 4 weeks, and 8 weeks

Secondary outcomes

1

frequency and severity of adverse events

Safety and tolerability, assessed by the frequency and severity of adverse events documented systematically using CTCAE v5.0 criteria

Time frame
Week 1, 2, 4, 6, and 8
2

Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) score

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.

Time frame
Weeks 1, 2, 4, 6, and 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bangladesh Medical University

Lead sponsor

Source ClinicalTrials.gov
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