Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New pain drug mirogabalin tested in Real-World diabetes study

NCT ID NCT06812117

Symptom relief Sponsor: Daiichi Sankyo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is tracking over 700 Chinese adults with diabetic peripheral neuropathic pain who are starting mirogabalin. Researchers are monitoring side effects and how well the drug works in everyday medical practice. The goal is to see if mirogabalin is a safe and effective option for this type of nerve pain.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mirogabalin
What this could lead to
If successful, this study could confirm that mirogabalin is a safe and effective option for managing diabetic nerve pain in everyday clinical practice.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. Side effects like dizziness and sleepiness are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

721 people

The number who actually took part.

Started

Jan 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Diabetic peripheral neuropathic pain are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

diabetic neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic peripheral neuropathic pain

Contacts and locations

Locations

  • Beijing Pinggu Hospital

    Beijing, 101200, China

  • Chengdu Fifth People's Hospital

    Chengdu, 611130, China

  • Chengdu First People's Hospital

    Chengdu, 610041, China

  • China-Japan friendship hospital

    Beijing, 100013, China

  • First Hospital of Shanxi Medical University

    Taiyuan, 030001, China

  • Fujian Medical University Union Hospital

    Fuzhou, 350001, China

  • Guangdong Provincial People's Hospital

    Guangzhou, 510000, China

  • Huadong Hospital

    Shanghai, 200040, China

  • Huashan Hospital Fudan University

    Shanghai, 200040, China

  • Nanfang Hospital of Southern Medical University

    Guangzhou, 510515, China

  • Nanyang First People's Hospital

    Nanyang, 473000, China

  • Peking Union Medical College Hospital

    Beijing, 100730, China

  • Pingxiang People's Hospital

    Pingxiang, 337005, China

  • Qingdao Municipal Hospital

    Qingdao, 266001, China

  • Renji Hospital, Shanghai Jiaotong University School Of Medicine

    Shanghai, 200001, China

  • Shanghai Tenth People's Hospital

    Shanghai, 200080, China

  • Shenzhen Nanshan People's Hospital

    Shenzhen, 518020, China

  • Shunde Hospital of southern Medical University

    Foshan, 528300, China

  • Sichuan Provincial People's Hospital

    Chengdu, 610072, China

  • Taizhou People's Hospital

    Taizhou, 225300, China

  • The Affiliated Hospital of Nanjing University Medical School

    Nanjing, 210008, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, 266003, China

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

    Henan, 471622, China

  • The First Affiliated Hospital of Jinan University

    Guangzhou, 510632, China

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang, 473000, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510080, China

  • The First People's Hospital Of Foshan

    Foshan, 528041, China

  • The First People's Hospital Of Yunnan

    Kunming, 650032, China

  • The Fourth Affiliated Hospital of Nanjing Medical University

    Nanjing, 225300, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, 310009, China

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, 400010, China

  • The Second Hospital of Tianjin Medical University

    Tianjin, 300211, China

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

    Wuhan, 430014, China

  • West China Hospital of Sichuan University

    Chengdu, 610041, China

  • Wuhan Central Hospital

    Wuhan, 430014, China

  • Wuhan Third Hospital

    Wuhan, 430050, China

  • Wuxi People's Hospital

    Wuxi, 214028, China

  • Xiangya Hospital of Central South University

    Changsha, 410008, China

  • Xuanwu Hospital Capital Medical University

    Beijing, 100053, China

  • Yibin Second People's Hospital

    Yibin, 644603, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, 310025, China

  • ZhongShan Hospital Fudan University

    Shanghai, 20032, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.