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)
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)
1 other identifier
observational
721
1 country
43
Brief Summary
This study will evaluate the safety and effectiveness of mirogabalin in adult patients with diabetic peripheral neuropathic pain (DPNP) in real-world clinical practice setting in China.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2025
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 24, 2025
CompletedFirst Submitted
Initial submission to the registry
January 31, 2025
CompletedFirst Posted
Study publicly available on registry
February 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 24, 2026
March 30, 2026
March 1, 2026
1.5 years
January 31, 2025
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of participants with any treatment related adverse events (TRAEs)
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Baseline to Week 14
Secondary Outcomes (9)
Time-to-onset of somnolence, dizziness, weight gain, and peripheral edema
Baseline to Week 14
Symptom duration of somnolence, dizziness, weight gain, and peripheral edema
Baseline to Week 14
Proportion of participants with TEAEs, serious TEAEs, TRAEs leading to study treatment discontinuation
Baseline to Week 14
Change from baseline in VAS pain
Week 14
Proportion of participants achieving 30% and 50% pain relief (reduction in VAS score compared to baseline)
Baseline to Week 14
- +4 more secondary outcomes
Study Arms (1)
Diabetic peripheral neuropathic pain (DPNP)
Patients diagnosed with DPNP and newly treated with mirogabalin.
Interventions
This is an non-interventional, observational study. No drug will be provided or administered as part of this protocol; however, participants on mirogabalin will be enrolled in this study.
Eligibility Criteria
Eligible patients diagnosed with DPNP and newly treated with mirogabalin will be consecutively enrolled in this study and followed up until the end of 15-week observation period, the end of 1-week observation period after the discontinuation of mirogabalin, withdrawal of consent, loss to follow-up, or study closure, whichever occurs first, to collect and evaluate patients' outcomes.
You may qualify if:
- Patients must meet all the following criteria to be eligible for this study.
- Age ≥ 18 years at the time of informed consent form (ICF) signed.
- Patients diagnosed with DPNP (defined as patients diagnosed with type 1 or type 2 diabetes and painful distal symmetric polyneuropathy).
- Patients with a pain scale of visual analog scale (VAS( ≥ 40 mm on the day of ICF signed.
- Patients who are mirogabalin naĂ¯ve prior to ICF signed and planned to initiate mirogabalin treatment.
- 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.
- Patients who have other severe pain unrelated to DPN at baseline, which may confound the assessment of DPNP.
- Patients who previously received pregabalin ≥ 300 mg/day or gabapentin ≥ 1200 mg/day to treat DPNP and declared lack of effectiveness.
- 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).
- Patients with major psychiatric disorders (depression, Alzheimer disease, Parkinson disease, mania, bipolar disorder, psychosis, or schizophrenia, etc.) at baseline.
- Patients with contraindications for mirogabalin treatment according to China package insert of mirogabalin.
- Patients with simultaneous participation in any interventional clinical study.
- Female patients at the status of pregnancy, potential pregnancy, or breast feeding.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (43)
China-Japan friendship hospital
Beijing, 100013, China
Xuanwu Hospital Capital Medical University
Beijing, 100053, China
Peking Union Medical College Hospital
Beijing, 100730, China
Beijing Pinggu Hospital
Beijing, 101200, China
Xiangya Hospital of Central South University
Changsha, 410008, China
Chengdu First People's Hospital
Chengdu, 610041, China
West China Hospital of Sichuan University
Chengdu, 610041, China
Sichuan Provincial People's Hospital
Chengdu, 610072, China
Chengdu Fifth People's Hospital
Chengdu, 611130, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, 400010, China
The First People's Hospital Of Foshan
Foshan, 528041, China
Shunde Hospital of southern Medical University
Foshan, 528300, China
Fujian Medical University Union Hospital
Fuzhou, 350001, China
Guangdong Provincial People's Hospital
Guangzhou, 510000, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, 510080, China
Nanfang Hospital of Southern Medical University
Guangzhou, 510515, China
The First Affiliated Hospital of Jinan University
Guangzhou, 510632, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, 310009, China
Zhejiang Provincial People's Hospital
Hangzhou, 310025, China
The First Affiliated Hospital of Henan University of Science & Technology
Henan, 471622, China
The First People's Hospital Of Yunnan
Kunming, 650032, China
The Affiliated Hospital of Nanjing University Medical School
Nanjing, 210008, China
The Fourth Affiliated Hospital of Nanjing Medical University
Nanjing, 225300, China
Nanyang First People's Hospital
Nanyang, 473000, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, 473000, China
Pingxiang People's Hospital
Pingxiang, 337005, China
Qingdao Municipal Hospital
Qingdao, 266001, China
The Affiliated Hospital of Qingdao University
Qingdao, 266003, China
Renji Hospital, Shanghai Jiaotong University School Of Medicine
Shanghai, 200001, China
Huadong Hospital
Shanghai, 200040, China
Huashan Hospital Fudan University
Shanghai, 200040, China
Shanghai Tenth People's Hospital
Shanghai, 200080, China
ZhongShan Hospital Fudan University
Shanghai, 20032, China
Shenzhen Nanshan People's Hospital
Shenzhen, 518020, China
First Hospital of Shanxi Medical University
Taiyuan, 030001, China
Taizhou People's Hospital
Taizhou, 225300, China
The Second Hospital of Tianjin Medical University
Tianjin, 300211, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430014, China
Wuhan Central Hospital
Wuhan, 430014, China
Wuhan Third Hospital
Wuhan, 430050, China
Wuxi People's Hospital
Wuxi, 214028, China
Yibin Second People's Hospital
Yibin, 644603, China
Related Publications (1)
Zhao L, Liu B, Chen H, Lu B, Wang W, Shi Y, Li M, Guo N, Fan B, Li X. Real-World Safety and Effectiveness of Mirogabalin in Chinese Adults with Diabetic Peripheral Neuropathic Pain: a Protocol of ReMIssion Study. Pain Ther. 2026 Mar 18. doi: 10.1007/s40122-026-00827-w. Online ahead of print.
PMID: 41849003DERIVED
Study Officials
- STUDY DIRECTOR
Project Manager
Daiichi Sankyo Co., Ltd.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2025
First Posted
February 6, 2025
Study Start
January 24, 2025
Primary Completion (Estimated)
July 24, 2026
Study Completion (Estimated)
July 24, 2026
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share