Evaluating Mirogabalin for Diabetic Nerve Pain in Adults

A Prospective, Observational, Multicenter 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)

This study is testing if the medication mirogabalin is safe and effective for adults with diabetic nerve pain in everyday medical settings.

Quick facts

• Study type: Observational
• Enrollment: 720 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Daiichi Sankyo (Industry-sponsored)
• Locations: 30 sites (Beijing and 29 other locations)
• Trial ID: NCT06812117 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of mirogabalin in adult patients suffering from diabetic peripheral neuropathic pain (DPNP) within real-world clinical settings in China. Although mirogabalin is approved for treating DPNP, there is limited real-world evidence on its effectiveness and safety across diverse patient populations, including those with various comorbidities and pain severity. The study aims to gather data that will assist physicians in making informed treatment decisions regarding mirogabalin for DPNP patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with diabetic peripheral neuropathic pain and are planning to initiate treatment with mirogabalin.

Not a fit: Patients with severe pain unrelated to diabetic peripheral neuropathic pain or those who have previously received high doses of pregabalin or gabapentin without effectiveness may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of mirogabalin, potentially improving treatment options for patients with diabetic peripheral neuropathic pain.

How similar studies have performed: While there is existing evidence on the safety and efficacy of mirogabalin, this study aims to fill a gap in real-world evidence, making it a novel approach.

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.

Where this trial is running

Beijing and 29 other locations

• China-Japan friendship hospital — Beijing, China (Not_yet_recruiting)
• Xuanwu Hospital Capital Medical University — Beijing, China (Not_yet_recruiting)
• Peking Union Medical College Hospital — Beijing, China (Not_yet_recruiting)
• Beijing Pinggu Hospital — Beijing, China (Not_yet_recruiting)
• Xiangya Hospital of Central South University — Changsha, China (Not_yet_recruiting)
• Chengdu First People's Hospital — Chengdu, China (Not_yet_recruiting)
• West China Hospital of Sichuan University — Chengdu, China (Not_yet_recruiting)
• Sichuan Provincial People's Hospital — Chengdu, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, China (Not_yet_recruiting)
• The First People's Hospital Of Foshan — Fo Shan Shi, China (Not_yet_recruiting)
• Shunde Hospital of southern Medical University — Foshan, China (Not_yet_recruiting)
• Fujian Medical University Union Hospital — Fuzhou, China (Not_yet_recruiting)
• Guangdong Provincial People's Hospital — Guangzhou, China (Not_yet_recruiting)
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, China (Not_yet_recruiting)
• Nanfang Hospital of Southern Medical University — Guangzhou, China (Not_yet_recruiting)
• The First Affiliated Hospital of Jinan University — Guangzhou, China (Not_yet_recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, China (Not_yet_recruiting)
• The First Affiliated Hospital of Henan University of Science & Technology — Henan, China (Not_yet_recruiting)
• The Affiliated Hospital of Nanjing University Medical School — Nanjing, China (Not_yet_recruiting)
• Pingxiang People's Hospital — Pingxiang, China (Not_yet_recruiting)
• Qingdao Municipal Hospital — Qingdao, China (Not_yet_recruiting)
• Huashan Hospital Fudan University — Shanghai, China (Not_yet_recruiting)
• Shanghai Tenth People's Hospital — Shanghai, China (Not_yet_recruiting)
• ZhongShan Hospital Fudan University — Shanghai, China (Recruiting)
• Shenzhen Nanshan People's Hospital — Shenzhen, China (Not_yet_recruiting)
• First Hospital of Shanxi Medical University — Taiyuan, China (Not_yet_recruiting)
• The Second Hospital of Tianjin Medical University — Tianjin, China (Not_yet_recruiting)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, China (Not_yet_recruiting)
• Wuxi People's Hospital — Wuxi, China (Not_yet_recruiting)
• Yibin Second People's Hospital — Yibin, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Contact for Clinical Trial Information

Conditions Diabetic Peripheral Neuropathic Pain; Diabetic peripheral neuropathic pain; Real-world evidence; Mirogabalin