A Study to Evaluate the Safety and Effectiveness of Mirogabalin in Chinese Adult Patients With Diabetic Peripheral Neuropathic Pain (DPNP) in Real-world Clinical Practice Setting (ReMIssion Study)

Launched by DAIICHI SANKYO · Jan 31, 2025

Keywords

ClinConnect Summary

The ReMIssion Study is a clinical trial that is looking at the safety and effectiveness of a medication called mirogabalin for adults suffering from diabetic peripheral neuropathic pain (DPNP). DPNP is a type of nerve pain that can occur in people with diabetes. This study is specifically taking place in real-world clinical settings in China and is currently recruiting participants. To be eligible, individuals need to be at least 18 years old, have a diagnosis of DPNP, and experience a certain level of pain. They should not have used certain other pain medications or have severe unrelated pain before joining the study.

If you decide to participate, you would start treatment with mirogabalin and help researchers understand how well it works for managing your pain in everyday life. Participants will need to provide consent and share their medical history. It’s important to note that individuals with certain health conditions or those who are pregnant or breastfeeding cannot participate. Overall, this study aims to gather valuable information about how mirogabalin can help people like you manage DPNP effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients must meet all the following criteria to be eligible for this study.
• • 1. Age ≥ 18 years at the time of informed consent form (ICF) signed.
• • 2. Patients diagnosed with DPNP (defined as patients diagnosed with type 1 or type 2 diabetes and painful distal symmetric polyneuropathy).
• • 3. Patients with a pain scale of visual analog scale (VAS( ≥ 40 mm on the day of ICF signed.
• • 4. Patients who are mirogabalin naïve prior to ICF signed and planned to initiate mirogabalin treatment.
• • 5. Patients who are able to give signed ICF for study participation and willing to provide access to previous and future medical information.
• • Patients who meet any of the following criteria will be excluded from this study.
• • 1. Patients who have other severe pain unrelated to DPN at baseline, which may confound the assessment of DPNP.
• • 2. Patients who previously received pregabalin ≥ 300 mg/day or gabapentin ≥ 1200 mg/day to treat DPNP and declared lack of effectiveness.
• • 3. Patients who received pregabalin, gabapentin, crisugabalin, or any other DPNP analgesic medications\* within 7 days prior to ICF signed.
• • \*Other DPNP analgesic medication includes TCAs (amitriptyline, nortriptyline), SNRIs (duloxetine, venlafaxine), antiepileptics (carbamazepine), opioids (tapentadol, tramadol).
• • 4. Patients with major psychiatric disorders (depression, Alzheimer disease, Parkinson disease, mania, bipolar disorder, psychosis, or schizophrenia, etc.) at baseline.
• • 5. Patients with contraindications for mirogabalin treatment according to China package insert of mirogabalin.
• • 6. Patients with simultaneous participation in any interventional clinical study.
• • 7. Female patients at the status of pregnancy, potential pregnancy, or breast feeding.
• • 8. Patients who have been judged by the investigator to be unsuitable to participate in the study.