Study of Mirogabalin for Central Neuropathic Pain

Central Neuropathic Pain Clinical Trial

Official title:

An Asian, Multicenter, Randomized, Double-blind, Placebo-controlled, 14-week Study of Mirogabalin in Participants With Central Neuropathic Pain Followed by a 52-week, Open-label Extension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03901352
• Other study ID #: DS5565-A-J314
• Secondary ID: 194653
• Status: Completed
• Phase: Phase 3
• Start date: March 12, 2019
• Est. completion date: December 28, 2020

Study information

• Verified date: February 2021
• 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 participants with central neuropathic pain in comparison to placebo

Description:

[Double Blind Phase] The primary objective is to compare change in the Average Daily Pain Score (ADPS) from baseline to Week 14 in Asian participants with central neuropathic pain (central neuropathic pain after spinal cord injury) receiving mirogabalin versus placebo.

[Open Extension Phase] The objective is to assess the long-term safety and efficacy of mirogabalin in participants with central neuropathic pain (central neuropathic pain after spinal cord injury, central post stroke pain, and central neuropathic pain in Parkinson's disease).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 28, 2020
• Est. primary completion date: December 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Spinal cord injury (SCI) due to trauma

• American Spinal Injury Association impairment scale A, B, C, or D

Exclusion Criteria:

• Other severe pain at screening or randomization, unrelated to central neuropathic pain after SCI, that may confound the assessment of central neuropathic pain after SCI

• Neurologic disorders at screening or randomization, unrelated to central neuropathic pain after SCI, that may confound the assessment of central neuropathic pain after SCI

• Major psychiatric disorders within 1 year prior to screening

Related Conditions & MeSH terms

• Central Neuropathic Pain
• Neuralgia

Intervention

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

Locations

Country	Name	City	State
Japan	Chubu-Rosai Hospital	Aichi
Japan	Honmachi Clinic	Aichi
Japan	Kainan Hospital	Aichi
Japan	Nagoya City West Medical Center	Aichi
Japan	Nagoya Tokushukai General Hospital	Aichi
Japan	Social Medical Corporation Daido Clinic	Aichi
Japan	Toyota Kosei Hospital	Aichi
Japan	Hachinohe City Hospital	Aomori
Japan	Hirosaki University Hospital	Aomori
Japan	Chiba Rehabilitation Center	Chiba
Japan	Chiba University Hospital	Chiba
Japan	Funabashi Municipal Medical Center	Chiba
Japan	Kimitsu Chuo Hospital	Chiba
Japan	Ehime Prefectural Central Hospital	Ehime
Japan	Fukui-ken Saiseikai Hospital	Fukui
Japan	University of Fukui Hospital	Fukui
Japan	Go Neurosurgical Clinic	Fukuoka
Japan	Japan Organization of Occupational Health and Safety Spinal Injuries Center	Fukuoka
Japan	Kyushu Rosai Hospital	Fukuoka
Japan	Shin Komonji Hospital	Fukuoka
Japan	Shin Yukuhashi Hospital	Fukuoka
Japan	Steel Memorial Yawata Hospital	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Southern TOHOKU Medical Clinic	Fukushima
Japan	Japanese Red Cross Maebashi Hospital	Gunma
Japan	Goodlife Hospital	Hiroshima
Japan	Hiroshima City Asa Citizens Hospital	Hiroshima
Japan	Hiroshima Prefectural Hospital	Hiroshima
Japan	Medical Corporation Suiseikai Suiseikai Kajikawa Hospital	Hiroshima
Japan	Hakodate Municipal Hospital	Hokkaido
Japan	Hokkaido Spinal Cord Injury Center	Hokkaido
Japan	Japanese Red Cross Asahikawa Hospital	Hokkaido
Japan	Nakamura Memorial Hospital	Hokkaido
Japan	Sapporo City General Hospital	Hokkaido
Japan	Sapporo Medical University Hospital	Hokkaido
Japan	Teine Keijinkai Hospital	Hokkaido
Japan	Hyogo Social Welfare Corporation Hyogo Rehabilitation Center Central Hospital	Hyogo
Japan	Japanese Red Cross Kobe Hospital	Hyogo
Japan	Japanese Red Cross Society Himeji Hospital	Hyogo
Japan	Kobe City Medical Center General Hospital	Hyogo
Japan	Ibaraki Seinan Medical Center Hospital	Ibaraki
Japan	University of Tsukuba Hospital	Ibaraki
Japan	Ishikawa Prefectural Central Hospital	Ishikawa
Japan	Iwate Rehabilitation Center	Iwate
Japan	Kagawa Prefectural Central Hospital	Kagawa
Japan	Shikoku Medical Center for Children and Adults	Kagawa
Japan	Japan Organization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital	Kanagawa
Japan	Kanagawa Rehabilitation Hospital	Kanagawa
Japan	Sagamihara Kyodo Hospital	Kanagawa
Japan	Yokohama City Minato Red Cross Hospital	Kanagawa
Japan	Yokohama City University Hospital	Kanagawa
Japan	Kumamoto Kinoh Hospital	Kumamoto
Japan	Kumamoto Rehabilitation Hospital	Kumamoto
Japan	Kumamoto Takumadai Rehabilitation Hospital	Kumamoto
Japan	National Hospital Organaization Kumamoto Medical Center	Kumamoto
Japan	Uji-Tokushukai Medical Center	Kyoto
Japan	Mie University Hospital	Mie
Japan	Katta General Hospital	Miyagi
Japan	National Hospital Organization Sendai Medical Center	Miyagi
Japan	Tohoku Rosai Hospital	Miyagi
Japan	Junwakai Memorial Hospital	Miyazaki
Japan	University of Miyazaki Hospital	Miyazaki
Japan	Japan Red Cross Society Azumino Hospital	Nagano
Japan	Nagasaki Rosai Hospital	Nagasaki
Japan	Nagasaki University Hospital	Nagasaki
Japan	Nara Prefecture General Rehabilitation Center	Nara
Japan	Japanese Red Cross Society Nagaoka Red Cross Hospital	Niigata
Japan	Nagaoka Chuo General Hospital	Niigata
Japan	Niigata City General Hospital	Niigata
Japan	Niigata University Medical & Dental Hospital	Niigata
Japan	Medical Corporation Keiaikai Nakamura Hospital	Oita
Japan	Kibikogen Rehabilitation Center For Employment Injuries	Okayama
Japan	Okayama City General Medical Center Okayama City Hospital	Okayama
Japan	Medical Corporation Tapic Okinawa Rehabilitation Center Hospital	Okinawa
Japan	Aijinkai Rehabilitation Hospital	Osaka
Japan	Osaka General Medical Center	Osaka
Japan	Osaka Rosai Hospital	Osaka
Japan	Osaka University Hospital	Osaka
Japan	Saga-ken Medical Centre KOSEIKAN	Saga
Japan	Hanyu General Hospital	Saitama
Japan	Otsu City Hospital	Shiga
Japan	Saiseikai Shiga Hospital	Shiga
Japan	Shimane University Hospital	Shimane
Japan	Fujieda Municipal General Hospital	Shizuoka
Japan	Hamamatsu University Hospital	Shizuoka
Japan	Japanese Red Cross Hamamatsu Hospital	Shizuoka
Japan	Kikugawa General Hospital	Shizuoka
Japan	Shizuoka City Shimizu Hospital	Shizuoka
Japan	Dokkyo Medical University Hospital	Tochigi
Japan	Jichi Medical University Hospital	Tochigi
Japan	Tokushima University Hospital	Tokushima
Japan	Makita General Hospital	Tokyo
Japan	National Hospital Organaization Murayama Medical Center	Tokyo
Japan	Nihon University Itabashi Hospital	Tokyo
Japan	Tottori University Hospital	Tottori
Japan	Toyama University Hospital Hospital	Toyama
Japan	Wakayama Medical University Hospital	Wakayama
Japan	Sanyudo Rehabilitation Center	Yamagata
Japan	Yamaguchi Rosai Hospital	Yamaguchi
Japan	Yamaguchi University Hospital	Yamaguchi
Japan	Yamanashi Prefectural Central Hospital	Yamanashi
Korea, Republic of	Daegu Fatima Hospital	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Ajou University Hospital	Gyeonggi-do
Korea, Republic of	CHA Bundang Medical Center	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	The Catholic University of Korea Incheon St. Mary's Hospital	Gyeonggi-do
Korea, Republic of	The Catholic University of Korea St. Vincent's Hospital	Gyeonggi-do
Korea, Republic of	Chonbuk National University Hospital	Jeollabuk-do
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Pusan National University Yangsan Hospital	Pusan
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul Universtiy Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul
Taiwan	Hualien Tzu Chi Hospital	Hualien
Taiwan	National Taiwan University Hospital	Taipei city
Taiwan	Taipei Veterans General Hospital	Taipei city
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Average Daily Pain Score (ADPS) Response 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)	Participants rate their pain in three parts of the questionnaire, which are combined into a single pain intensity score: Part 1 - fifteen descriptors of pain intensity, on a scale of 0 (none) to 3 (severe); Part 2 - a 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; Part 3 - a Present Pain Intensity index in which the participant rates present pain intensity on a scale of 0 (no pain) to 5 (most intense pain)	Baseline to 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.	Baseline to Week 14