A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain
1 other identifier
interventional
393
1 country
40
Brief Summary
Investigate the efficacy and safety of mirogabalin in Chinese participants with diabetic peripheral neuropathic pain in comparison to placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2019
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2019
CompletedStudy Start
First participant enrolled
September 18, 2019
CompletedFirst Posted
Study publicly available on registry
September 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 24, 2022
CompletedOctober 24, 2022
October 1, 2022
2.3 years
September 17, 2019
October 20, 2022
Conditions
Outcome Measures
Primary Outcomes (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.
Baseline to Week 14
Secondary Outcomes (6)
ADPS responder rate
at Week 14
Pain Intensity Score Using the Short-Form McGill Pain Questionnaire (SF-MPQ): Visual Analog Scale (VAS)
at Week 14
Patient Global Impression of Change
at Week 14
Average Daily Sleep Interference score (ADSIS)
at Week 14
Medical Outcome Study (MOS) sleep scale
at Week 14
- +1 more secondary outcomes
Other Outcomes (1)
Actigraphy signal collected from a wrist-worn medical-grade sensor
at Week 14
Study Arms (2)
Mirogabalin
EXPERIMENTALMirogabalin 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks maintenance dose.
Placebo
PLACEBO COMPARATORPlacebo (14-weeks)
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Beijing Chaoyang Hospital, Capital Medical University
Beijing, 100020, China
Peking University First Hospital
Beijing, 100034, China
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050, China
Xuanwu Hospital Capital Medical University
Beijing, 100053, China
Special Medical Center of Chinese PLA Rocket Force
Beijing, 100088, China
Beijing PingGu Hospital
Beijing, 101200, China
Cangzhou Central Hospital
Cangzhou, 061001, China
Jilin Province People's Hospital
Changchun, 130021, China
The First Hospital of Changsha
Changsha, 410005, China
The Second Xiangya Hospital of Central South University
Changsha, 410011, China
Peace Hospital Affiliated to Changzhi Medical College
Changzhi, 046000, China
West China Hospital, Sichuan University
Chengdu, 610041, China
The Fourth People's Hospital of Chongqing
Chongqing, 400010, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, 116001, China
Foshan First People's Hospital
Foshan, 528000, China
Nanfang Hospital of Southern Medical Hospital
Guangzhou, 510515, China
Guizhou Provincial People's Hospital
Guizhou, 550002, China
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022, China
Jiaxing Second Hospital
Jiaxing, 314000, China
Jilin Central General Hospital
Jilin, 132011, China
The First Affiliated Hospital of Jinzhou Medical University
Jingzhou, 121001, China
Yunnan First People's Hospital
Kunming, 650032, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, 471000, China
Luoyang Central Hospital Affiliated to Zhengzhou University
Luoyang, 471009, China
Jiangxi Pingxiang People's Hospital
Pingxiang, 337055, China
The Affiliated Hospital of Qingdao University
Qingdao, 266071, China
Shanghai Huashan Hospital
Shanghai, 200040, China
Shanghai Tenth People's Hospital
Shanghai, 200072, China
Yangpu Hospital,Tongji University
Shanghai, 200090, China
Shanghai Pudong Hospital
Shanghai, 200135, China
Central Hospital of Minhang District Shanghai
Shanghai, 201199, China
Siping Central Hospital
Siping, 136000, China
The First Hospital of Shanxi Medical University
Taiyuan, 030001, China
The Second Hospital of Tianjin Medical University
Tianjin, 300211, China
The 2nd Affiliated Hospital of The 2nd School of Medicine, Wenzhou Medical University
Wenzhou, 325027, China
Renmin Hospital of Wuhan University (Hubei General Hospital)
Wuhan, 430060, China
Wuxi People's Hospital
Wuxi, 214023, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, 710061, China
The First Affiliated Hospital of Xiamen University
Xiamen, 361003, China
Zigong Fourth People's Hospital
Zigong, 643000, China
Related Publications (1)
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.
PMID: 38896199DERIVED
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Clinical Study Leader
Daiichi Sankyo
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2019
First Posted
September 19, 2019
Study Start
September 18, 2019
Primary Completion
January 17, 2022
Study Completion
January 24, 2022
Last Updated
October 24, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
- Access Criteria
- Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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/