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

Diabetic Peripheral Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04094662
• Other study ID #: DS5565-A-A315
• Status: Completed
• Phase: Phase 3
• Start date: September 18, 2019
• Est. completion date: January 24, 2022

Study information

• Verified date: October 2022
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 393
• Est. completion date: January 24, 2022
• Est. primary completion date: January 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathic Pain
• Neuralgia

Intervention

Drug:
• Mirogabalin
Mirogabalin tablets for oral administration
• Placebo
Matching placebo tablets for oral administration

Locations

Country	Name	City	State
China	Beijing Chaoyang Hospital, Capital Medical University	Beijing
China	Beijing Friendship Hospital, Capital Medical University	Beijing
China	Beijing PingGu Hospital	Beijing
China	Peking University First Hospital	Beijing
China	Special Medical Center of Chinese PLA Rocket Force	Beijing
China	Xuanwu Hospital Capital Medical University	Beijing
China	Cangzhou Central Hospital	Cangzhou
China	Jilin Province People's Hospital	Chang chun
China	The First Hospital of Changsha	Changsha
China	The Second Xiangya Hospital of Central South University	Changsha
China	Peace Hospital Affiliated to Changzhi Medical College	Changzhi
China	West China Hospital, Sichuan University	Chengdu
China	The Fourth People's Hospital of Chongqing	Chongqing
China	Affiliated Zhongshan Hospital of Dalian University	Dalian
China	Foshan First People's Hospital	Foshan
China	Nanfang Hospital of Southern Medical Hospital	Guangzhou
China	Guizhou Provincial People's Hospital	Guizhou
China	The First Affiliated Hospital of Anhui Medical University	Hefei
China	Jiaxing Second Hospital	Jiaxing
China	Jilin Central General Hospital	Jilin
China	The First Affiliated Hospital of Jinzhou Medical University	Jingzhou
China	Yunnan First People's Hospital	Kunming
China	Luoyang Central Hospital Affiliated to Zhengzhou University	Luoyang
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang
China	Jiangxi Pingxiang People's Hospital	Pingxiang
China	The Affiliated Hospital of Qingdao University	Qingdao
China	Central Hospital of Minhang District Shanghai	Shanghai
China	Shanghai Huashan Hospital	Shanghai
China	Shanghai Pudong Hospital	Shanghai
China	Shanghai Tenth People's Hospital	Shanghai
China	Yangpu Hospital,Tongji University	Shanghai
China	Siping Central Hospital	Siping
China	The First Hospital of Shanxi Medical University	Taiyuan
China	The Second Hospital of Tianjin Medical University	Tianjin
China	The 2nd Affiliated Hospital of The 2nd School of Medicine, Wenzhou Medical University	Wenzhou
China	Renmin Hospital of Wuhan University (Hubei General Hospital)	Wuhan
China	Wuxi People's Hospital	Wuxi
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an
China	The First Affiliated Hospital of Xiamen University	Xiamen
China	Zigong Fourth People's Hospital	Zigong

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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