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Diabetic Peripheral Neuropathic PainNCT06812117

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)

An observational study of Diabetic Peripheral Neuropathic Pain, run by Daiichi Sankyo at 43 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Peripheral Neuropathic Pain
What is being tested?
No Drug
How many people
721 participants
Where
43 sitesChina
Study dates
24 Jan 2025to 9 Apr 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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 naïve 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.
Show all 16Show fewer
  • 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.
  • Patients who have been judged by the investigator to be unsuitable to participate in the study.

Who cannot join

None listed.

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

China43 sites

  • China-Japan friendship hospital

    Beijing, 100013

  • Xuanwu Hospital Capital Medical University

    Beijing, 100053

  • Peking Union Medical College Hospital

    Beijing, 100730

  • Beijing Pinggu Hospital

    Beijing, 101200

  • Xiangya Hospital of Central South University

    Changsha, 410008

  • Chengdu First People's Hospital

    Chengdu, 610041

  • West China Hospital of Sichuan University

    Chengdu, 610041

  • Sichuan Provincial People's Hospital

    Chengdu, 610072

  • Chengdu Fifth People's Hospital

    Chengdu, 611130

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, 400010

  • The First People's Hospital Of Foshan

    Foshan, 528041

  • Shunde Hospital of southern Medical University

    Foshan, 528300

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

  • Guangdong Provincial People's Hospital

    Guangzhou, 510000

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, 510080

  • Nanfang Hospital of Southern Medical University

    Guangzhou, 510515

  • The First Affiliated Hospital of Jinan University

    Guangzhou, 510632

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, 310009

  • Zhejiang Provincial People's Hospital

    Hangzhou, 310025

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

    Henan, 471622

  • The First People's Hospital Of Yunnan

    Kunming, 650032

  • The Affiliated Hospital of Nanjing University Medical School

    Nanjing, 210008

  • The Fourth Affiliated Hospital of Nanjing Medical University

    Nanjing, 225300

  • Nanyang First People's Hospital

    Nanyang, 473000

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang, 473000

  • Pingxiang People's Hospital

    Pingxiang, 337005

  • Qingdao Municipal Hospital

    Qingdao, 266001

  • The Affiliated Hospital of Qingdao University

    Qingdao, 266003

  • Renji Hospital, Shanghai Jiaotong University School Of Medicine

    Shanghai, 200001

  • Huadong Hospital

    Shanghai, 200040

  • Huashan Hospital Fudan University

    Shanghai, 200040

  • Shanghai Tenth People's Hospital

    Shanghai, 200080

  • ZhongShan Hospital Fudan University

    Shanghai, 20032

  • Shenzhen Nanshan People's Hospital

    Shenzhen, 518020

  • First Hospital of Shanxi Medical University

    Taiyuan, 030001

  • Taizhou People's Hospital

    Taizhou, 225300

  • The Second Hospital of Tianjin Medical University

    Tianjin, 300211

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

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

    Wuhan, 430014

  • Wuhan Central Hospital

    Wuhan, 430014

  • Wuhan Third Hospital

    Wuhan, 430050

  • Wuxi People's Hospital

    Wuxi, 214028

  • Yibin Second People's Hospital

    Yibin, 644603

Other trials in China

About this 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)

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.

Read the 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.

Being tested
No Drug
Keywords
Diabetic peripheral neuropathic pain, Real-world evidence, Mirogabalin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No DrugOther

    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.

Study groups in NCT06812117
Study groupRoleWhat they receive
Diabetic peripheral neuropathic pain (DPNP)Patients diagnosed with DPNP and newly treated with mirogabalin.
Receives: Other: No Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to Week 14

Secondary outcomes (9)

  1. Time-to-onset of somnolence, dizziness, weight gain, and peripheral edema

    For time-to-event variables, the median time, Q1 and Q3 as well as 95% CI will be estimated.

    Measured: Baseline to Week 14

  2. Symptom duration of somnolence, dizziness, weight gain, and peripheral edema

    For time-to-event variables, the median time, Q1 and Q3 as well as 95% CI will be estimated.

    Measured: Baseline to Week 14

  3. Proportion of participants with TEAEs, serious TEAEs, TRAEs leading to study treatment discontinuation

    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.

    Measured: Baseline to Week 14

  4. Change from baseline in VAS pain

    The VAS is used for the participant to rate average pain intensity of past 24 hours on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain. Reductions in VAS pain scores indicate better clinical outcome.

    Measured: Week 14

  5. Proportion of participants achieving 30% and 50% pain relief (reduction in VAS score compared to baseline)

    The VAS is used for the participant to rate average pain intensity of past 24 hours on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain. Reductions in VAS pain scores indicate better clinical outcome.

    Measured: Baseline to Week 14

  6. Time to achieve 30% pain relief or 50% pain relief (reduction in VAS score compared to baseline)

    The VAS is used for the participant to rate average pain intensity of past 24 hours on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain. Reductions in VAS pain scores indicate better clinical outcome.

    Measured: Baseline to Week 14

  7. Change from baseline in Douleur Neuropathique 4 questions (DN4) score

    DN4 will be assessed by the investigator after ICF signed and prior to the first administration of mirogabalin as baseline, when participants return to the clinical site during treatment period of mirogabalin, and at the end of mirogabalin treatment.

    Each "yes" answer is assigned 1 point, and a total score is calculated. A score of 4 or higher indicates a higher likelihood of neuropathic pain (eg. worse clinical outcome), while a score below 3 suggests it is less likely (eg. better clinical outcome).

    Measured: Week 14

  8. Patient Global Impression of Change (PGIC)

    Participants will provide a self-assessment using the 7-point scale via ePRO at the end of mirogabalin treatment: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse. Lower PGIC scores indicate better clinical outcome.

    Measured: Week 14

  9. Change from baseline in EuroQol 5-Dimension 5-level (EQ-5D-5L)

    The self-administered EQ-5D-5L includes the EQ-5D and the EQ VAS. EQ-5D comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3-moderate problems, 4=severe problems and 5=extreme problems. The patient is asked to indicate his/her health state in each of the five dimensions, resulting in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Lower 5-digit numbers indicates better clinical outcome (ie, health state).

    The EQ VAS records the patient's self-rated health on a vertical VAS where the endpoints are labelled '100 - The best health you can imagine' and '0 - The worst health you can imagine'. Higher EQ VAS scores indicate better clinical outcome/health.

    Measured: Week 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2025
  2. Study start24 Jan 2025
  3. Primary completion9 Apr 2026
  4. Study completion9 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
721 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06812117
Sponsor's protocol ID
DS5565-0002-NIS-MA
Status last verified
Oct 2026
First submitted
31 Jan 2025
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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 Jun;15(3):905-920. doi: 10.1007/s40122-026-00827-w. Epub 2026 Mar 18.

    PubMed 41849003

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Peripheral Neuropathic Pain, run by Daiichi Sankyo at 43 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with any treatment related adverse events (TRAEs) (time frame: Baseline to Week 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06812117, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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