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)

Last updated: February 5, 2025
Sponsor: Daiichi Sankyo
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain (Pediatric)

Pain

Treatment

No Drug

Clinical Study ID

NCT06812117
DS5565-0002-NIS-MA
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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).

  1. Patients with major psychiatric disorders (depression, Alzheimer disease, Parkinson disease, mania, bipolar disorder, psychosis, or schizophrenia, etc.) at baseline.

  2. Patients with contraindications for mirogabalin treatment according to China package insert of mirogabalin.

  3. Patients with simultaneous participation in any interventional clinical study.

  4. Female patients at the status of pregnancy, potential pregnancy, or breast feeding.

  5. Patients who have been judged by the investigator to be unsuitable to participate in the study.

Study Design

Total Participants: 720
Treatment Group(s): 1
Primary Treatment: No Drug
Phase:
Study Start date:
January 25, 2025
Estimated Completion Date:
April 13, 2026

Study 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.

Connect with a study center

  • Beijing Pinggu Hospital

    Beijing, 101200
    China

    Site Not Available

  • China-Japan friendship hospital

    Beijing, 100013
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, 100730
    China

    Site Not Available

  • Xuanwu Hospital Capital Medical University

    Beijing, 100053
    China

    Site Not Available

  • Xiangya Hospital of Central South University

    Changsha, 410008
    China

    Site Not Available

  • Chengdu First People's Hospital

    Chengdu, 610041
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu, 610072
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, 610041
    China

    Site Not Available

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, 400010
    China

    Site Not Available

  • The First People's Hospital Of Foshan

    Fo Shan Shi, 528041
    China

    Site Not Available

  • Shunde Hospital of southern Medical University

    Foshan, 528300
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, 350001
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou, 510000
    China

    Site Not Available

  • Nanfang Hospital of Southern Medical University

    Guangzhou, 510515
    China

    Site Not Available

  • The First Affiliated Hospital of Jinan University

    Guangzhou, 510632
    China

    Site Not Available

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510080
    China

    Site Not Available

  • Zhejiang Provincial People's Hospital

    Hangzhou, 310025
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University of Science & Technology

    Henan, 471622
    China

    Site Not Available

  • The Affiliated Hospital of Nanjing University Medical School

    Nanjing, 210008
    China

    Site Not Available

  • Pingxiang People's Hospital

    Pingxiang, 337005
    China

    Site Not Available

  • Qingdao Municipal Hospital

    Qingdao, 266001
    China

    Site Not Available

  • Huashan Hospital Fudan University

    Shanghai, 200040
    China

    Site Not Available

  • Shanghai Tenth People's Hospital

    Shanghai, 200080
    China

    Site Not Available

  • ZhongShan Hospital Fudan University

    Shanghai, 20032
    China

    Active - Recruiting

  • Shenzhen Nanshan People's Hospital

    Shenzhen, 518020
    China

    Site Not Available

  • First Hospital of Shanxi Medical University

    Taiyuan, 030001
    China

    Site Not Available

  • The Second Hospital of Tianjin Medical University

    Tianjin, 300211
    China

    Site Not Available

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430014
    China

    Site Not Available

  • Wuxi People's Hospital

    Wuxi, 214028
    China

    Site Not Available

  • Yibin Second People's Hospital

    Yibin, 644603
    China

    Site Not Available

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