Clinical trial NCT03901352: Study of Mirogabalin for Central Neuropathic Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Central Neuropathic Pain
Keywords: Central neuropathic pain
Developmental phase III
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2019-04-03
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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).

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

Primary outcomes:
measure: Change From Baseline in the Weekly Average Daily Pain Score (ADPS) at Week 14 Following Administration With Mirogabalin or Placebo
timeFrame: Baseline to Week 14 postdose
Secondary outcomes:
measure: Number of Participants With ≥30% Reduction and ≥50% Reductions From Baseline in Average Daily Pain Score (ADPS)
timeFrame: Baseline to Week 14 postdose
measure: Change From Baseline in Present Pain Intensity on the Short Form-McGill Pain Questionnaire at Week 14 Following Administration With Mirogabalin or Placebo
timeFrame: Baseline to Week 14 postdose
measure: Patient Global Impression of Change at Week 14 Following Administration With Mirogabalin or Placebo
timeFrame: at Week 14 postdose
measure: Change From Baseline in the Weekly Average Daily Sleep Interference Score (ADSIS) Following Administration With Mirogabalin or Placebo
timeFrame: Baseline to Week 14 postdose
measure: Change From Baseline in the Medical Outcomes Study Sleep Scale Scores Following Administration With Mirogabalin or Placebo
timeFrame: Baseline to Week 14 postdose
measure: Change From Baseline in the Hospital Anxiety & Depression Scale Following Administration With Mirogabalin or Placebo
timeFrame: Baseline to Week 14 postdose
measure: Change From Baseline in the Neuropathic Pain Symptom Inventory Score Following Administration With Mirogabalin or Placebo
timeFrame: Baseline to Week 14 postdose
measure: Change From Baseline in the EuroQoL 5 Dimensions 5 Levels Following Administration With Mirogabalin or Placebo
timeFrame: Baseline to Week 14 postdose
measure: Change From Baseline in the Spinal Cord Independence Measure Scores Following Administration With Mirogabalin or Placebo
timeFrame: Baseline to Week 14 postdose
measure: Number of Participants Who Performed At Level or Below Level for Allodynia Following Administration With Mirogabalin or Placebo
timeFrame: Baseline to Week 14 postdose
measure: Change From Baseline in Present Pain Intensity on the Short Form-McGill Pain Questionnaire at Week 52 Following Administration With Mirogabalin During the Long-term Extension (LTE)
timeFrame: Baseline to Week 52 postdose
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Chubu-Rosai Hospital
city: Aichi
country: Japan
facility: Social Medical Corporation Daido Clinic
city: Aichi
country: Japan
facility: Honmachi Clinic
city: Aichi
country: Japan
facility: Nagoya City West Medical Center
city: Aichi
country: Japan
facility: Toyota Kosei Hospital
city: Aichi
country: Japan
facility: Nagoya Tokushukai General Hospital
city: Aichi
country: Japan
facility: Kainan Hospital
city: Aomori
country: Japan
facility: Hachinohe City Hospital
city: Aomori
country: Japan
facility: Hirosaki University Hospital
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Chiba
country: Japan
facility: Chiba Rehabilitation Center
city: Chiba
country: Japan
facility: Funabashi Municipal Medical Center
city: Chiba
country: Japan
facility: Kimitsu Chuo Hospital
city: Ehime
country: Japan
facility: Ehime Prefectural Central Hospital
city: Fukui
country: Japan
facility: University of Fukui Hospital
city: Fukui
country: Japan
facility: Fukui-ken Saiseikai Hospital
city: Fukuoka
country: Japan
facility: Shin Komonji Hospital
city: Fukuoka
country: Japan
facility: Kyushu Rosai Hospital
city: Fukuoka
country: Japan
facility: Steel Memorial Yawata Hospital
city: Fukuoka
country: Japan
facility: Go Neurosurgical Clinic
city: Fukuoka
country: Japan
facility: Japan Organization of Occupational Health and Safety Spinal Injuries Center
city: Fukuoka
country: Japan
facility: Shin Yukuhashi Hospital
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Fukushima
country: Japan
facility: Southern TOHOKU Medical Clinic
city: Gunma
country: Japan
facility: Japanese Red Cross Maebashi Hospital
city: Hiroshima
country: Japan
facility: Goodlife Hospital
city: Hiroshima
country: Japan
facility: Medical Corporation Suiseikai Suiseikai Kajikawa Hospital
city: Hiroshima
country: Japan
facility: Hiroshima City Asa Citizens Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Prefectural Hospital
city: Hokkaido
country: Japan
facility: Teine Keijinkai Hospital
city: Hokkaido
country: Japan
facility: Hakodate Municipal Hospital
city: Hokkaido
country: Japan
facility: Sapporo Medical University Hospital
city: Hokkaido
country: Japan
facility: Nakamura Memorial Hospital
city: Hokkaido
country: Japan
facility: Sapporo City General Hospital
city: Hokkaido
country: Japan
facility: Japanese Red Cross Asahikawa Hospital
city: Hokkaido
country: Japan
facility: Hokkaido Spinal Cord Injury Center
city: Hyōgo
country: Japan
facility: Kobe City Medical Center General Hospital
city: Hyōgo
country: Japan
facility: Japanese Red Cross Kobe Hospital
city: Hyōgo
country: Japan
facility: Hyogo Social Welfare Corporation Hyogo Rehabilitation Center Central Hospital
city: Hyōgo
country: Japan
facility: Japanese Red Cross Society Himeji Hospital
city: Ibaraki
country: Japan
facility: University of Tsukuba Hospital
city: Ibaraki
country: Japan
facility: Ibaraki Seinan Medical Center Hospital
city: Ishikawa
country: Japan
facility: Ishikawa Prefectural Central Hospital
city: Iwate
country: Japan
facility: Iwate Rehabilitation Center
city: Kagawa
country: Japan
facility: Kagawa Prefectural Central Hospital
city: Kagawa
country: Japan
facility: Shikoku Medical Center for Children and Adults
city: Kanagawa
country: Japan
facility: Japan Organization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital
city: Kanagawa
country: Japan
facility: Yokohama City Minato Red Cross Hospital
city: Kanagawa
country: Japan
facility: Yokohama City University Hospital
city: Kanagawa
country: Japan
facility: Kanagawa Rehabilitation Hospital
city: Kanagawa
country: Japan
facility: Sagamihara Kyodo Hospital
city: Kumamoto
country: Japan
facility: National Hospital Organaization Kumamoto Medical Center
city: Kumamoto
country: Japan
facility: Kumamoto Kinoh Hospital
city: Kumamoto
country: Japan
facility: Kumamoto Takumadai Rehabilitation Hospital
city: Kumamoto
country: Japan
facility: Kumamoto Rehabilitation Hospital
city: Kyoto
country: Japan
facility: Uji-Tokushukai Medical Center
city: Mie
country: Japan
facility: Mie University Hospital
city: Miyagi
country: Japan
facility: Tohoku Rosai Hospital
city: Miyagi
country: Japan
facility: National Hospital Organization Sendai Medical Center
city: Miyagi
country: Japan
facility: Katta General Hospital
city: Miyazaki
country: Japan
facility: Junwakai Memorial Hospital
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital
city: Nagano
country: Japan
facility: Japan Red Cross Society Azumino Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Nagasaki
country: Japan
facility: Nagasaki Rosai Hospital
city: Nara
country: Japan
facility: Nara Prefecture General Rehabilitation Center
city: Niigata
country: Japan
facility: Japanese Red Cross Society Nagaoka Red Cross Hospital
city: Niigata
country: Japan
facility: Nagaoka Chuo General Hospital
city: Niigata
country: Japan
facility: Niigata City General Hospital
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Okayama
country: Japan
facility: Okayama City General Medical Center Okayama City Hospital
city: Okayama
country: Japan
facility: Kibikogen Rehabilitation Center For Employment Injuries
city: Okinawa
country: Japan
facility: Medical Corporation Tapic Okinawa Rehabilitation Center Hospital
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Osaka
country: Japan
facility: Osaka University Hospital
city: Osaka
country: Japan
facility: Aijinkai Rehabilitation Hospital
city: Osaka
country: Japan
facility: Osaka Rosai Hospital
city: Saga
country: Japan
facility: Saga-ken Medical Centre KOSEIKAN
city: Saitama
country: Japan
facility: Hanyu General Hospital
city: Shiga
country: Japan
facility: Otsu City Hospital
city: Shiga
country: Japan
facility: Saiseikai Shiga Hospital
city: Shimane
country: Japan
facility: Shimane University Hospital
city: Shizuoka
country: Japan
facility: Shizuoka City Shimizu Hospital
city: Shizuoka
country: Japan
facility: Fujieda Municipal General Hospital
city: Shizuoka
country: Japan
facility: Hamamatsu University Hospital
city: Shizuoka
country: Japan
facility: Japanese Red Cross Hamamatsu Hospital
city: Shizuoka
country: Japan
facility: Kikugawa General Hospital
city: Tochigi
country: Japan
facility: Dokkyo Medical University Hospital
city: Tochigi
country: Japan
facility: Jichi Medical University Hospital
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Tokyo
country: Japan
facility: Makita General Hospital
city: Tokyo
country: Japan
facility: Nihon University Itabashi Hospital
city: Tokyo
country: Japan
facility: National Hospital Organaization Murayama Medical Center
city: Tottori
country: Japan
facility: Tottori University Hospital
city: Toyama
country: Japan
facility: Toyama University Hospital Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Yamagata
country: Japan
facility: Sanyudo Rehabilitation Center
city: Yamaguchi
country: Japan
facility: Yamaguchi University Hospital
city: Yamaguchi
country: Japan
facility: Yamaguchi Rosai Hospital
city: Yamanashi
country: Japan
facility: Yamanashi Prefectural Central Hospital
city: Ōita
country: Japan
facility: Medical Corporation Keiaikai Nakamura Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Fatima Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: CHA Bundang Medical Center
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent's Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea Incheon St. Mary's Hospital
city: Jeollabuk-do
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Universtiy Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Hualien
country: Taiwan
facility: Hualien Tzu Chi Hospital
city: Taipei city
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei city
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Daiichi Sankyo
name: Clinical Study Leader
role: STUDY_DIRECTOR
References: