Clinical trial NCT06812117: 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)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Peripheral Neuropathic Pain
Keywords: Diabetic peripheral neuropathic pain
Real-world evidence
Mirogabalin
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2025-02-06
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: Mirogabalin has been approved in China for the treatment of DPNP. Although there is evidence of the safety and efficacy of mirogabalin, there is a lack of real-world evidence on its safety and effectiveness to inform decision-making among a more diverse patient population in real-world clinical practice, such as patients with moderate or severe renal impairment; patients with more complications, comorbidities, and treatments; and patients with different severity of pain.

This study aims to collect safety and effectiveness data to guide physicians in the clinical use of mirogabalin for the treatment of patients with DPNP in the real-world clinical practice setting.

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.

Primary outcomes:
measure: Proportion of participants with any treatment related adverse events (TRAEs)
timeFrame: Baseline to Week 14
Secondary outcomes:
measure: Time-to-onset of somnolence, dizziness, weight gain, and peripheral edema
timeFrame: Baseline to Week 14
measure: Symptom duration of somnolence, dizziness, weight gain, and peripheral edema
timeFrame: Baseline to Week 14
measure: Proportion of participants with TEAEs, serious TEAEs, TRAEs leading to study treatment discontinuation
timeFrame: Baseline to Week 14
measure: Change from baseline in VAS pain
timeFrame: Week 14
measure: Proportion of participants achieving 30% and 50% pain relief (reduction in VAS score compared to baseline)
timeFrame: Baseline to Week 14
measure: Time to achieve 30% pain relief or 50% pain relief (reduction in VAS score compared to baseline)
timeFrame: Baseline to Week 14
measure: Change from baseline in Douleur Neuropathique 4 questions (DN4) score
timeFrame: Week 14
measure: Patient Global Impression of Change (PGIC)
timeFrame: Week 14
measure: Change from baseline in EuroQol 5-Dimension 5-level (EQ-5D-5L)
timeFrame: Week 14
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan friendship hospital
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Beijing Pinggu Hospital
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
city: Chengdu
country: China
facility: Chengdu First People's Hospital
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
city: Fo Shan Shi
country: China
facility: The First People's Hospital Of Foshan
city: Foshan
country: China
facility: Shunde Hospital of southern Medical University
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
city: Henan
country: China
facility: The First Affiliated Hospital of Henan University of Science & Technology
city: Nanjing
country: China
facility: The Affiliated Hospital of Nanjing University Medical School
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
city: Shanghai
country: China
facility: ZhongShan Hospital Fudan University
city: Shenzhen
country: China
facility: Shenzhen Nanshan People's Hospital
city: Taiyuan
country: China
facility: First Hospital of Shanxi Medical University
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
city: Wuxi
country: China
facility: Wuxi People's Hospital
city: Yibin
country: China
facility: Yibin Second People's Hospital
Study officials:
affiliation: Daiichi Sankyo (China) Holdings Co., Ltd.
name: Project Manager
role: STUDY_DIRECTOR
References: