Study of Mirogabalin for Central Neuropathic Pain

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

Sponsors

Lead Sponsor: Daiichi Sankyo Co., Ltd.

Source Daiichi Sankyo, Inc.
Brief Summary

Investigate the efficacy and safety of mirogabalin in participants with central neuropathic pain in comparison to placebo

Detailed 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).

Overall Status Active, not recruiting
Start Date March 12, 2019
Completion Date January 31, 2021
Primary Completion Date January 31, 2021
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Average Daily Pain Score (ADPS) Baseline to Week 14
Secondary Outcome
Measure Time Frame
Average Daily Pain Score (ADPS) Response Rate at Week 14
Pain Intensity Score Using the Short-Form McGill Pain Questionnaire (SF-MPQ) Baseline to Week 14
Patient Global Impression of Change at Week 14
Average Daily Sleep Interference score (ADSIS) Baseline to Week 14
Enrollment 274
Condition
Intervention

Intervention Type: Drug

Intervention Name: Placebo

Description: Matching placebo tablets for oral administration

Arm Group Label: Placebo

Other Name: Matching Placebo

Intervention Type: Drug

Intervention Name: Mirogabalin

Description: Mirogabalin tablets for oral administration

Arm Group Label: Mirogabalin

Other Name: DS-5565

Eligibility

Criteria:

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

Gender: All

Minimum Age: 20 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Clinical Study Leader Study Director Daiichi Sankyo, Inc.
Location
Facility:
Chubu-Rosai Hospital | Aichi, 455-8530, Japan
Social Medical Corporation Daido Clinic | Aichi, 457-8511, Japan
Honmachi Clinic | Aichi, 460-0008, Japan
Nagoya City West Medical Center | Aichi, 462-8508, Japan
Toyota Kosei Hospital | Aichi, 470-0396, Japan
Nagoya Tokushukai General Hospital | Aichi, 487-0016, Japan
Kainan Hospital | Aichi, 498-8502, Japan
Hachinohe City Hospital | Aomori, 031-8555, Japan
Hirosaki University Hospital | Aomori, 036-8563, Japan
Chiba University Hospital | Chiba, 260-8677, Japan
Chiba Rehabilitation Center | Chiba, 266-0005, Japan
Funabashi Municipal Medical Center | Chiba, 273-8588, Japan
Kimitsu Chuo Hospital | Chiba, 292-8535, Japan
Ehime Prefectural Central Hospital | Ehime, 790-0024, Japan
University of Fukui Hospital | Fukui, 910-1193, Japan
Fukui-ken Saiseikai Hospital | Fukui, 918-8503, Japan
Shin Komonji Hospital | Fukuoka, 800-0057, Japan
Kyushu Rosai Hospital | Fukuoka, 800-0296, Japan
Steel Memorial Yawata Hospital | Fukuoka, 805-8508, Japan
Go Neurosurgical Clinic | Fukuoka, 811-1244, Japan
Japan Organization of Occupational Health and Safety Spinal Injuries Center | Fukuoka, 820-8508, Japan
Shin Yukuhashi Hospital | Fukuoka, 824-0026, Japan
Fukushima Medical University Hospital | Fukushima, 960-1295, Japan
Southern TOHOKU Medical Clinic | Fukushima, 963-8052, Japan
Japanese Red Cross Maebashi Hospital | Gunma, 371-0811, Japan
Goodlife Hospital | Hiroshima, 720-0052, Japan
Medical Corporation Suiseikai Suiseikai Kajikawa Hospital | Hiroshima, 730-0053, Japan
Hiroshima City Asa Citizens Hospital | Hiroshima, 731-0293, Japan
Hiroshima Prefectural Hospital | Hiroshima, 734-8530, Japan
Teine Keijinkai Hospital | Hokkaido, 006-8555, Japan
Hakodate Municipal Hospital | Hokkaido, 041-8680, Japan
Sapporo Medical University Hospital | Hokkaido, 060-8543, Japan
Nakamura Memorial Hospital | Hokkaido, 060-8570, Japan
Sapporo City General Hospital | Hokkaido, 060-8604, Japan
Japanese Red Cross Asahikawa Hospital | Hokkaido, 070-8530, Japan
Hokkaido Spinal Cord Injury Center | Hokkaido, 072-0015, Japan
Kobe City Medical Center General Hospital | Hyōgo, 650-0047, Japan
Japanese Red Cross Kobe Hospital | Hyōgo, 651-0073, Japan
Hyogo Social Welfare Corporation Hyogo Rehabilitation Center Central Hospital | Hyōgo, 651-2181, Japan
Japanese Red Cross Society Himeji Hospital | Hyōgo, 670-8540, Japan
University of Tsukuba Hospital | Ibaraki, 305-8576, Japan
Ibaraki Seinan Medical Center Hospital | Ibaraki, 306-0433, Japan
Ishikawa Prefectural Central Hospital | Ishikawa, 920-8530, Japan
Iwate Rehabilitation Center | Iwate, 020-0503, Japan
Kagawa Prefectural Central Hospital | Kagawa, 760-8557, Japan
Shikoku Medical Center for Children and Adults | Kagawa, 765-8597, Japan
Japan Organization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital | Kanagawa, 222-0036, Japan
Yokohama City Minato Red Cross Hospital | Kanagawa, 231-8682, Japan
Yokohama City University Hospital | Kanagawa, 236-0004, Japan
Kanagawa Rehabilitation Hospital | Kanagawa, 243-0121, Japan
Sagamihara Kyodo Hospital | Kanagawa, 252-5188, Japan
National Hospital Organaization Kumamoto Medical Center | Kumamoto, 860-0008, Japan
Kumamoto Kinoh Hospital | Kumamoto, 860-8518, Japan
Kumamoto Takumadai Rehabilitation Hospital | Kumamoto, 862-0924, Japan
Kumamoto Rehabilitation Hospital | Kumamoto, 869-1106, Japan
Uji-Tokushukai Medical Center | Kyoto, 611-0041, Japan
Mie University Hospital | Mie, 514-8507, Japan
Tohoku Rosai Hospital | Miyagi, 981-8563, Japan
National Hospital Organization Sendai Medical Center | Miyagi, 983-8520, Japan
Katta General Hospital | Miyagi, 989-0231, Japan
Junwakai Memorial Hospital | Miyazaki, 880-2112, Japan
University of Miyazaki Hospital | Miyazaki, 889-1692, Japan
Japan Red Cross Society Azumino Hospital | Nagano, 399-8292, Japan
Nagasaki University Hospital | Nagasaki, 852-8501, Japan
Nagasaki Rosai Hospital | Nagasaki, 857-0134, Japan
Nara Prefecture General Rehabilitation Center | Nara, 636-0345, Japan
Japanese Red Cross Society Nagaoka Red Cross Hospital | Niigata, 940-2485, Japan
Nagaoka Chuo General Hospital | Niigata, 940-8653, Japan
Niigata City General Hospital | Niigata, 950-1197, Japan
Niigata University Medical & Dental Hospital | Niigata, 951-8520, Japan
Okayama City General Medical Center Okayama City Hospital | Okayama, 700-8557, Japan
Kibikogen Rehabilitation Center For Employment Injuries | Okayama, 716-1241, Japan
Medical Corporation Tapic Okinawa Rehabilitation Center Hospital | Okinawa, 904-2173, Japan
Osaka General Medical Center | Osaka, 558-8558, Japan
Osaka University Hospital | Osaka, 565-0871, Japan
Aijinkai Rehabilitation Hospital | Osaka, 569-1116, Japan
Osaka Rosai Hospital | Osaka, 591-8025, Japan
Saga-ken Medical Centre KOSEIKAN | Saga, 840-8571, Japan
Hanyu General Hospital | Saitama, 348-8505, Japan
Otsu City Hospital | Shiga, 520-0804, Japan
Saiseikai Shiga Hospital | Shiga, 520-3046, Japan
Shimane University Hospital | Shimane, 693-8501, Japan
Shizuoka City Shimizu Hospital | Shizuoka, 424-8636, Japan
Fujieda Municipal General Hospital | Shizuoka, 426-8677, Japan
Hamamatsu University Hospital | Shizuoka, 431-3192, Japan
Japanese Red Cross Hamamatsu Hospital | Shizuoka, 434-8533, Japan
Kikugawa General Hospital | Shizuoka, 439-0022, Japan
Dokkyo Medical University Hospital | Tochigi, 321-0293, Japan
Jichi Medical University Hospital | Tochigi, 329-0498, Japan
Tokushima University Hospital | Tokushima, 770-8503, Japan
Makita General Hospital | Tokyo, 143-8505, Japan
Nihon University Itabashi Hospital | Tokyo, 173-8610, Japan
National Hospital Organaization Murayama Medical Center | Tokyo, 208-0011, Japan
Tottori University Hospital | Tottori, 683-8504, Japan
Toyama University Hospital Hospital | Toyama, 930-0194, Japan
Wakayama Medical University Hospital | Wakayama, 641-8510, Japan
Sanyudo Rehabilitation Center | Yamagata, 992-0057, Japan
Yamaguchi University Hospital | Yamaguchi, 755-8505, Japan
Yamaguchi Rosai Hospital | Yamaguchi, 756-0095, Japan
Yamanashi Prefectural Central Hospital | Yamanashi, 400-8506, Japan
Medical Corporation Keiaikai Nakamura Hospital | Ōita, 874-0937, Japan
Daegu Fatima Hospital | Daegu, 41199, Korea, Republic of
Chungnam National University Hospital | Daejeon, 35015, Korea, Republic of
CHA Bundang Medical Center | Gyeonggi-do, 13496, Korea, Republic of
Seoul National University Bundang Hospital | Gyeonggi-do, 13620, Korea, Republic of
The Catholic University of Korea St. Vincent's Hospital | Gyeonggi-do, 16247, Korea, Republic of
Ajou University Hospital | Gyeonggi-do, 16499, Korea, Republic of
The Catholic University of Korea Incheon St. Mary's Hospital | Gyeonggi-do, 21431, Korea, Republic of
Chonbuk National University Hospital | Jeollabuk-do, 54907, Korea, Republic of
Pusan National University Hospital | Pusan, 49241, Korea, Republic of
Pusan National University Yangsan Hospital | Pusan, 50612, Korea, Republic of
Seoul Universtiy Hospital | Seoul, 03080, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital | Seoul, 06591, Korea, Republic of
Samsung Medical Center | Seoul, 6351, Korea, Republic of
Hualien Tzu Chi Hospital | Hualien, 97002, Taiwan
National Taiwan University Hospital | Taipei city, 10002, Taiwan
Taipei Veterans General Hospital | Taipei city, 11217, Taiwan
Chang Gung Memorial Hospital | Taoyuan, 33305, Taiwan
Location Countries

Japan

Korea, Republic of

Taiwan

Verification Date

June 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Mirogabalin

Type: Experimental

Description: The patients with creatinine clearance (CLcr) ≥ 60 mL/min: Mirogabalin 20 mg or 30 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks maintenance dose. The patients with creatinine clearance (CLcr) 30 to < 60 mL/min: Mirogabalin 10 mg or 15 mg, oral administration, Treatment period; 2-weeks titration and 12-weeks maintenance dose

Label: Placebo

Type: Placebo Comparator

Description: Placebo (14-weeks)

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: During the Double-blind Phase, participants will be randomized into parallel treatment arms. During the Open Extension Phase, all participants will be assigned to a single group.

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Masking Description: During the Double-blind Phase, masking will be triple (as shown above). During the Open Extension Phase, there will be no masking - the allocation is not applicable.

Source: ClinicalTrials.gov