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Diabetic Peripheral Neuropathic PainPhase 3NCT04094662

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain

A Phase 3 study testing Mirogabalin in people with Diabetic Peripheral Neuropathic Pain, run by Daiichi Sankyo Co., Ltd. at 40 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

Investigate the efficacy and safety of mirogabalin in Chinese participants with diabetic peripheral neuropathic pain in comparison to placebo. 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?
Mirogabalin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
393 participants
Where
40 sitesChina
Study dates
18 Sep 2019to 24 Jan 2022
Phase
Phase 3
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

Who may be able to join

  • Type 1 or type 2 diabetes mellitus at screening
  • Painful distal symmetric polyneuropathy, diagnosed at least 6 months prior to screening (see Procedures manual for the Diagnosis of Diabetic Peripheral Neuropathy and Neurological Examination for details)

Who cannot join

  • HbA1c (National Glycohemoglobin Standardization Program) > 10.0% at screening
  • Uncontrolled blood glucose within 1 month prior to screening, at screening or randomization
  • Other severe pain at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP
  • Neurologic disorders at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP
  • Major psychiatric disorders at screening or randomization
  • Creatinine clearance (using the Cockcroft-Gault equation) < 60 mL/min at screening

Trial locations and contacts

40 sites in 1 country.

40 sites in 1 country

China40 sites

  • Beijing Chaoyang Hospital, Capital Medical University

    Beijing, 100020

  • Peking University First Hospital

    Beijing, 100034

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, 100050

  • Xuanwu Hospital Capital Medical University

    Beijing, 100053

  • Special Medical Center of Chinese PLA Rocket Force

    Beijing, 100088

  • Beijing PingGu Hospital

    Beijing, 101200

  • Cangzhou Central Hospital

    Cangzhou, 061001

  • Jilin Province People's Hospital

    Changchun, 130021

  • The First Hospital of Changsha

    Changsha, 410005

  • The Second Xiangya Hospital of Central South University

    Changsha, 410011

  • Peace Hospital Affiliated to Changzhi Medical College

    Changzhi, 046000

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • The Fourth People's Hospital of Chongqing

    Chongqing, 400010

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian, 116001

  • Foshan First People's Hospital

    Foshan, 528000

  • Nanfang Hospital of Southern Medical Hospital

    Guangzhou, 510515

  • Guizhou Provincial People's Hospital

    Guizhou, 550002

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, 230022

  • Jiaxing Second Hospital

    Jiaxing, 314000

  • Jilin Central General Hospital

    Jilin City, 132011

  • The First Affiliated Hospital of Jinzhou Medical University

    Jingzhou, 121001

  • Yunnan First People's Hospital

    Kunming, 650032

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

    Luoyang, 471000

  • Luoyang Central Hospital Affiliated to Zhengzhou University

    Luoyang, 471009

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, 337055

  • The Affiliated Hospital of Qingdao University

    Qingdao, 266071

  • Shanghai Huashan Hospital

    Shanghai, 200040

  • Shanghai Tenth People's Hospital

    Shanghai, 200072

  • Yangpu Hospital,Tongji University

    Shanghai, 200090

  • Shanghai Pudong Hospital

    Shanghai, 200135

  • Central Hospital of Minhang District Shanghai

    Shanghai, 201199

  • Siping Central Hospital

    Siping, 136000

  • The First Hospital of Shanxi Medical University

    Taiyuan, 030001

  • The Second Hospital of Tianjin Medical University

    Tianjin, 300211

  • The 2nd Affiliated Hospital of The 2nd School of Medicine, Wenzhou Medical University

    Wenzhou, 325027

  • Renmin Hospital of Wuhan University (Hubei General Hospital)

    Wuhan, 430060

  • Wuxi People's Hospital

    Wuxi, 214023

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, 710061

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003

  • Zigong Fourth People's Hospital

    Zigong, 643000

Other trials in China

About this study

Investigate the efficacy and safety of mirogabalin in Chinese participants with diabetic peripheral neuropathic pain in comparison to placebo.

Read the detailed description

The primary objective is to compare change from baseline in weekly Average Daily Pain Score (ADPS) at Week 14 in Chinese patients with Diabetic Peripheral Neuropathic Pain (DPNP) receiving mirogabalin versus placebo.

Being tested
Mirogabalin, Placebo

What participants receive

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

  • MirogabalinDrug

    Also called DS-5565

    Mirogabalin tablets for oral administration

  • PlaceboDrug

    Matching placebo tablets for oral administration

Study groups in NCT04094662
Study groupRoleWhat they receive
MirogabalinExperimentalMirogabalin 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks maintenance dose.
Receives: Drug: Mirogabalin
PlaceboPlacebo comparatorPlacebo (14-weeks)
Receives: Drug: Placebo

What is being measured

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

  1. Average Daily Pain Score (ADPS)

    The pain scores on a scale of 0-10, where 0 = no pain and 10 = the worst possible pain. The weekly ADPS is based on participants daily pain scores.

    Measured: Baseline to Week 14

Secondary outcomes (6)

  1. ADPS responder rate

    Ratio of Participants Responding to Treatment, as Measured by Average Daily Pain Score (ADPS) Reduction from Baseline. The ADPS is used to determine categorical response rates.

    Measured: at Week 14

  2. Pain Intensity Score Using the Short-Form McGill Pain Questionnaire (SF-MPQ): Visual Analog Scale (VAS)

    The VAS, in which the participant rates pain on a 100 mm-long horizontal line, where 0 mm = no pain and 100 mm = worst possible pain.

    Measured: at Week 14

  3. Patient Global Impression of Change

    Participants rate their overall impression of how the present pain compares to baseline using a 7-point scale, where 1 = very much improved and 7 = very much worse. Patient Global Impression of Change scores are used to determine categorical responder rates.

    Measured: at Week 14

  4. Average Daily Sleep Interference score (ADSIS)

    The sleep interference scores on a scale of 0-10, where 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep. The weekly ADSIS is based on participants daily sleep interference scores.

    Measured: at Week 14

  5. Medical Outcome Study (MOS) sleep scale

    Participants rate their sleep quality during the past 4 weeks in three parts of the questionnaire:

    Part 1 - The participants rate the average time required to fall asleep, 0-15 minutes = 1, 16-30 minutes = 2, 31-45 minutes = 3, 46-60 minutes = 4, More than 60 minutes = 5.

    Part 2 - The participants give the number of hours per night for the average hours of sleep per night.

    Part 3 - The participants using a score of 1 (all of the time) to 5 (none of the time) to rate their sleep disturbance in the following areas: difficulty in falling asleep or remaining asleep, difficulty in staying awake during the day, difficulty in breathing, and snoring during sleep.

    Measured: at Week 14

  6. Five Level EuroQol-5D (EQ-5D) version

    Participants rate their Quality of Life in the following dimensions: mobility (5-point scale), self-care (5-point scale), usual activities (5-point scale), pain/discomfort (5-point scale), and anxiety/depression(5-point scale) that are combined into an overall health utilities index. Participants also rate their perception of overall health using VAS, with zero indicating worst health and 100 representing best imaginable health.

    Measured: at 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 posted19 Sep 2019
  2. Study start18 Sep 2019
  3. Primary completion17 Jan 2022
  4. Study completion24 Jan 2022

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
393 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04094662
Sponsor's protocol ID
DS5565-A-A315
Status last verified
Oct 2022
First submitted
17 Sep 2019
Last updated
24 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Publications

  • Guo X, Yu Y, Zhang Y, Sun L, Li Y, Song B, Hang L, Baba M, Wasaki Y, Kikumori K, Murayama E. A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled 14-Week Study of Mirogabalin in Chinese Patients with Diabetic Peripheral Neuropathic Pain. Pain Ther. 2024 Aug;13(4):937-952. doi: 10.1007/s40122-024-00617-2. Epub 2024 Jun 19.

    PubMed 38896199

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mirogabalin in people with Diabetic Peripheral Neuropathic Pain, run by Daiichi Sankyo Co., Ltd. at 40 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 2 inclusion and 6 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 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Average Daily Pain Score (ADPS) (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 NCT04094662, 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 24 Oct 2022; AzTrials last refreshed its copy on 27 Oct 2026.

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