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

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

Study Overview

• Status: Completed
• Conditions: Diabetic Peripheral Neuropathic Pain
• Intervention / Treatment: Drug: Placebo; Drug: Mirogabalin

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.

• Study Type: Interventional
• Enrollment (Actual): 393
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100034
    • Peking University First Hospital
  • Beijing, China, 100020
    • Beijing Chaoyang Hospital, Capital Medical University
  • Beijing, China, 100053
    • Xuanwu Hospital Capital Medical University
  • Beijing, China, 100050
    • Beijing Friendship Hospital, Capital Medical University
  • Beijing, China, 100088
    • Special Medical Center of Chinese PLA Rocket Force
  • Beijing, China, 101200
    • Beijing Pinggu Hospital
  • Cangzhou, China, 061001
    • Cangzhou Central Hospital
  • Chang chun, China, 130021
    • Jilin Province People's Hospital
  • Changsha, China, 410005
    • The First Hospital of Changsha
  • Changsha, China, 410011
    • The second Xiangya Hospital of Central South University
  • Changzhi, China, 046000
    • Peace Hospital Affiliated to Changzhi Medical College
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University
  • Chongqing, China, 400010
    • The fourth people's hospital of chongqing
  • Dalian, China, 116001
    • Affiliated Zhongshan Hospital of Dalian University
  • Foshan, China, 528000
    • Foshan First People's Hospital
  • Guangzhou, China, 510515
    • Nanfang Hospital of Southern Medical Hospital
  • Guizhou, China, 550002
    • Guizhou Provincial People's Hospital
  • Hefei, China, 230022
    • The First affiliated Hospital of Anhui Medical University
  • Jiaxing, China, 314000
    • Jiaxing Second Hospital
  • Jilin, China, 132011
    • Jilin Central General Hospital
  • Jingzhou, China, 121001
    • The First Affiliated Hospital of Jinzhou Medical University
  • Kunming, China, 650032
    • Yunnan First People's Hospital
  • Luoyang, China, 471000
    • The First Affiliated Hospital of Henan University of Science and Technology
  • Luoyang, China, 471009
    • Luoyang Central Hospital Affiliated To Zhengzhou University
  • Pingxiang, China, 337055
    • Jiangxi Pingxiang People's Hospital
  • Qingdao, China, 266071
    • The Affiliated Hospital of Qingdao University
  • Shanghai, China, 200072
    • Shanghai Tenth People's Hospital
  • Shanghai, China, 200040
    • Shanghai Huashan Hospital
  • Shanghai, China, 200090
    • Yangpu Hospital,Tongji University
  • Shanghai, China, 200135
    • Shanghai Pudong Hospital
  • Shanghai, China, 201199
    • Central Hospital of Minhang District Shanghai
  • Siping, China, 136000
    • Siping Central Hospital
  • Taiyuan, China, 030001
    • The First Hospital of Shanxi Medical University
  • Tianjin, China, 300211
    • The Second Hospital of Tianjin Medical University
  • Wenzhou, China, 325027
    • The 2nd Affiliated Hospital of The 2nd School of Medicine, Wenzhou Medical University
  • Wuhan, China, 430060
    • Renmin Hospital of Wuhan University (Hubei General Hospital)
  • Wuxi, China, 214023
    • Wuxi People's Hospital
  • Xi'an, China, 710061
    • The First Affiliated Hospital of Xi'an Jiaotong University
  • Xiamen, China, 361003
    • The First Affiliated Hospital of Xiamen University
  • Zigong, China, 643000
    • Zigong Fourth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo (14-weeks)	Drug: Placebo; Matching placebo tablets for oral administration
Experimental: Mirogabalin; Mirogabalin 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks maintenance dose.	Drug: Mirogabalin; Mirogabalin tablets for oral administration; Other Names: DS-5565

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at Week 14
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.	at Week 14
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.	at Week 14
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.	at Week 14
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.	at Week 14
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.	at Week 14

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Actigraphy signal collected from a wrist-worn medical-grade sensor	Result of physical activity during waking hours and participants' sleep will be evaluated to explore a relationship between participants reported outcomes and actigraphy signal collected from a wrist-worn medical-grade sensor (ActiGraph GT9X Link). Only participants who signed a separate informed consent form for wearing medical-grade sensor will be included in this evaluation.	at Week 14

Collaborators and Investigators

• Sponsor: Daiichi Sankyo Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2019
• Primary Completion (Actual): January 17, 2022
• Study Completion (Actual): January 24, 2022

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 20, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Diabetic Neuropathies
• Other Study ID Numbers: DS5565-A-A315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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/
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No