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Central Neuropathic PainPhase 3NCT03901352

Study of Mirogabalin for Central Neuropathic Pain

A Phase 3 study testing Mirogabalin in people with Central Neuropathic Pain, run by Daiichi Sankyo Co., Ltd. at 118 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Investigate the efficacy and safety of mirogabalin in participants with central neuropathic pain in comparison to placebo Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Central Neuropathic Pain
What is being tested?
Mirogabalin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
118 sitesin 3 countries
Study dates
12 Mar 2019to 28 Dec 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Spinal cord injury (SCI) due to trauma
  • American Spinal Injury Association impairment scale A, B, C, or D

Who cannot join

  • 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

Trial locations and contacts

118 sites in 3 countries.

118 sites in 3 countries

Japan101 sites

  • Chubu-Rosai Hospital

    Aichi, 455-8530

  • Social Medical Corporation Daido Clinic

    Aichi, 457-8511

  • Honmachi Clinic

    Aichi, 460-0008

  • Nagoya City West Medical Center

    Aichi, 462-8508

  • Toyota Kosei Hospital

    Aichi, 470-0396

  • Nagoya Tokushukai General Hospital

    Aichi, 487-0016

  • Kainan Hospital

    Aichi, 498-8502

  • Hachinohe City Hospital

    Aomori, 031-8555

  • Hirosaki University Hospital

    Aomori, 036-8563

  • Chiba University Hospital

    Chiba, 260-8677

  • Chiba Rehabilitation Center

    Chiba, 266-0005

  • Funabashi Municipal Medical Center

    Chiba, 273-8588

  • Kimitsu Chuo Hospital

    Chiba, 292-8535

  • Ehime Prefectural Central Hospital

    Ehime, 790-0024

  • University of Fukui Hospital

    Fukui, 910-1193

  • Fukui-ken Saiseikai Hospital

    Fukui, 918-8503

  • Shin Komonji Hospital

    Fukuoka, 800-0057

  • Kyushu Rosai Hospital

    Fukuoka, 800-0296

  • Steel Memorial Yawata Hospital

    Fukuoka, 805-8508

  • Go Neurosurgical Clinic

    Fukuoka, 811-1244

  • Japan Organization of Occupational Health and Safety Spinal Injuries Center

    Fukuoka, 820-8508

  • Shin Yukuhashi Hospital

    Fukuoka, 824-0026

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

  • Southern TOHOKU Medical Clinic

    Fukushima, 963-8052

  • Japanese Red Cross Maebashi Hospital

    Gunma, 371-0811

  • Goodlife Hospital

    Hiroshima, 720-0052

  • Medical Corporation Suiseikai Suiseikai Kajikawa Hospital

    Hiroshima, 730-0053

  • Hiroshima City Asa Citizens Hospital

    Hiroshima, 731-0293

  • Hiroshima Prefectural Hospital

    Hiroshima, 734-8530

  • Teine Keijinkai Hospital

    Hokkaido, 006-8555

  • Hakodate Municipal Hospital

    Hokkaido, 041-8680

  • Sapporo Medical University Hospital

    Hokkaido, 060-8543

  • Nakamura Memorial Hospital

    Hokkaido, 060-8570

  • Sapporo City General Hospital

    Hokkaido, 060-8604

  • Japanese Red Cross Asahikawa Hospital

    Hokkaido, 070-8530

  • Hokkaido Spinal Cord Injury Center

    Hokkaido, 072-0015

  • Kobe City Medical Center General Hospital

    Hyōgo, 650-0047

  • Japanese Red Cross Kobe Hospital

    Hyōgo, 651-0073

  • Hyogo Social Welfare Corporation Hyogo Rehabilitation Center Central Hospital

    Hyōgo, 651-2181

  • Japanese Red Cross Society Himeji Hospital

    Hyōgo, 670-8540

  • University of Tsukuba Hospital

    Ibaraki, 305-8576

  • Ibaraki Seinan Medical Center Hospital

    Ibaraki, 306-0433

  • Ishikawa Prefectural Central Hospital

    Ishikawa, 920-8530

  • Kagawa Prefectural Central Hospital

    Kagawa, 760-8557

  • Shikoku Medical Center for Children and Adults

    Kagawa, 765-8597

  • Japan Organization of Occupational Health and Safety(JOHAS), Yokohama Rosai Hospital

    Kanagawa, 222-0036

  • Yokohama City Minato Red Cross Hospital

    Kanagawa, 231-8682

  • Yokohama City University Hospital

    Kanagawa, 236-0004

  • Kanagawa Rehabilitation Hospital

    Kanagawa, 243-0121

  • Sagamihara Kyodo Hospital

    Kanagawa, 252-5188

  • National Hospital Organaization Kumamoto Medical Center

    Kumamoto, 860-0008

  • Kumamoto Kinoh Hospital

    Kumamoto, 860-8518

  • Kumamoto Takumadai Rehabilitation Hospital

    Kumamoto, 862-0924

  • Kumamoto Rehabilitation Hospital

    Kumamoto, 869-1106

  • Uji-Tokushukai Medical Center

    Kyoto, 611-0041

  • Mie University Hospital

    Mie, 514-8507

  • Tohoku Rosai Hospital

    Miyagi, 981-8563

  • National Hospital Organization Sendai Medical Center

    Miyagi, 983-8520

  • Katta General Hospital

    Miyagi, 989-0231

  • Junwakai Memorial Hospital

    Miyazaki, 880-2112

  • University of Miyazaki Hospital

    Miyazaki, 889-1692

  • Japan Red Cross Society Azumino Hospital

    Nagano, 399-8292

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • Nagasaki Rosai Hospital

    Nagasaki, 857-0134

  • Nara Prefecture General Rehabilitation Center

    Nara, 636-0345

  • Japanese Red Cross Society Nagaoka Red Cross Hospital

    Niigata, 940-2485

  • Nagaoka Chuo General Hospital

    Niigata, 940-8653

  • Niigata City General Hospital

    Niigata, 950-1197

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8520

  • Iwate Rehabilitation Center

    Numakunai, 020-0503

  • Medical Corporation Keiaikai Nakamura Hospital

    Ōita, 874-0937

  • Okayama City General Medical Center Okayama City Hospital

    Okayama, 700-8557

  • Kibikogen Rehabilitation Center For Employment Injuries

    Okayama, 716-1241

  • Medical Corporation Tapic Okinawa Rehabilitation Center Hospital

    Okinawa, 904-2173

  • Osaka General Medical Center

    Osaka, 558-8558

  • Osaka University Hospital

    Osaka, 565-0871

  • Aijinkai Rehabilitation Hospital

    Osaka, 569-1116

  • Osaka Rosai Hospital

    Osaka, 591-8025

  • Saga-ken Medical Centre KOSEIKAN

    Saga, 840-8571

  • Hanyu General Hospital

    Saitama, 348-8505

  • Otsu City Hospital

    Shiga, 520-0804

  • Saiseikai Shiga Hospital

    Shiga, 520-3046

  • Shimane University Hospital

    Shimane, 693-8501

  • Shizuoka City Shimizu Hospital

    Shizuoka, 424-8636

  • Fujieda Municipal General Hospital

    Shizuoka, 426-8677

  • Hamamatsu University Hospital

    Shizuoka, 431-3192

  • Japanese Red Cross Hamamatsu Hospital

    Shizuoka, 434-8533

  • Kikugawa General Hospital

    Shizuoka, 439-0022

  • Dokkyo Medical University Hospital

    Tochigi, 321-0293

  • Jichi Medical University Hospital

    Tochigi, 329-0498

  • Tokushima University Hospital

    Tokushima, 770-8503

  • Makita General Hospital

    Tokyo, 143-8505

  • Nihon University Itabashi Hospital

    Tokyo, 173-8610

  • National Hospital Organaization Murayama Medical Center

    Tokyo, 208-0011

  • Tottori University Hospital

    Tottori, 683-8504

  • Toyama University Hospital Hospital

    Toyama, 930-0194

  • Wakayama Medical University Hospital

    Wakayama, 641-8510

  • Sanyudo Rehabilitation Center

    Yamagata, 992-0057

  • Yamaguchi University Hospital

    Yamaguchi, 755-8505

  • Yamaguchi Rosai Hospital

    Yamaguchi, 756-0095

  • Yamanashi Prefectural Central Hospital

    Yamanashi, 400-8506

Other trials in Japan

South Korea13 sites

  • Daegu Fatima Hospital

    Daegu, 41199

  • Chungnam National University Hospital

    Daejeon, 35015

  • CHA Bundang Medical Center

    Gyeonggi-do, 13496

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • The Catholic University of Korea St. Vincent's Hospital

    Gyeonggi-do, 16247

  • Ajou University Hospital

    Gyeonggi-do, 16499

  • The Catholic University of Korea Incheon St. Mary's Hospital

    Gyeonggi-do, 21431

  • Chonbuk National University Hospital

    Jeollabuk-do, 54907

  • Pusan National University Hospital

    Pusan, 49241

  • Pusan National University Yangsan Hospital

    Pusan, 50612

  • Seoul Universtiy Hospital

    Seoul, 03080

  • The Catholic University of Korea Seoul St. Mary's Hospital

    Seoul, 06591

  • Samsung Medical Center

    Seoul, 6351

Other trials in South Korea

Taiwan4 sites

  • Hualien Tzu Chi Hospital

    Hualien City, 97002

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Memorial Hospital

    Taoyuan, 33305

Other trials in Taiwan

About this study

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

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

Read the 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).

Being tested
Placebo, Mirogabalin
Keywords
Central neuropathic pain, Developmental phase III

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Also called Matching Placebo

    Matching placebo tablets for oral administration

  • MirogabalinDrug

    Also called DS-5565

    Mirogabalin tablets for oral administration

Study groups in NCT03901352
Study groupRoleWhat they receive
MirogabalinExperimentalThe 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
Receives: Drug: Mirogabalin
PlaceboPlacebo comparatorPlacebo (14-weeks)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in the Weekly Average Daily Pain Score (ADPS) at Week 14 Following Administration With Mirogabalin or Placebo

    The pain scores on a scale of 0-10, where 0 = no pain and 10 = the worst possible pain. Negative changes in ADPS indicated an improvement in pain scores. The weekly ADPS is based on participants daily pain scores.

    Measured: Baseline to Week 14 postdose

Secondary outcomes (11)

  1. Number of Participants With ≥30% Reduction and ≥50% Reductions From Baseline in Average Daily Pain Score (ADPS)

    Responder rate (%) = 100 × (observed weekly ADPS - baseline weekly ADPS) / baseline weekly ADPS, where the baseline weekly ADPS was defined as the average of up to 7 available pain scores in the last 7 days at or before the randomization visit (Visit 2).

    Measured: Baseline to Week 14 postdose

  2. Change From Baseline in Present Pain Intensity on the Short Form-McGill Pain Questionnaire at Week 14 Following Administration With Mirogabalin or Placebo

    Participants rated their present pain intensity on a scale of 0 (no pain) to 5 (most intense pain). Negative changes in present pain intensity indicated an improvement in pain intensity.

    Measured: Baseline to Week 14 postdose

  3. Patient Global Impression of Change at Week 14 Following Administration With Mirogabalin or Placebo

    At the end-of-treatment (Visit 7)/early termination visit, participants provided a self-assessment of their condition compared to the randomization visit (Visit 2) using the 7-point scale in the Patient Global Impression of Change (PGIC), where 1 = very much improved to 7 = very much worse. Here, the PGIC responder rates were categorized and defined as the percentage of participants who satisfied the following PGIC score criteria: Minimally improved or better (ie, score ≤3); Much improved or better (ie, score ≤2). Patient Global Impression of Change scores are used to determine categorical responder rates.

    Measured: at Week 14 postdose

  4. Change From Baseline in the Weekly Average Daily Sleep Interference Score (ADSIS) Following Administration With Mirogabalin or Placebo

    The daily sleep interference diary consisted of an 11-point numerical rating scale (NRS) which was used to assess how pain had interfered with the participant's sleep during the past 24 hours. Participants recorded a sleep interference score in the patient diary once daily from the day after the screening visit (Visit 1) through the end-of-treatment (Visit 7)/early termination visit. Every morning upon awakening, prior to taking the study drug, each participant selected the number that best described his/her sleep interference experience during the past 24 hours on a scale of 0 = pain did not interfere with sleep to 10 = pain completely interfered with sleep. Negative values indicate an improvement in sleep interference. The weekly average daily sleep interference score (ADSIS) was based on the sleep interference scores from the patient diaries.

    Measured: Baseline to Week 14 postdose

  5. Change From Baseline in the Medical Outcomes Study Sleep Scale Scores Following Administration With Mirogabalin or Placebo

    The MOS sleep scale was based on questions about sleep quality during the past 4 weeks and consisted of 3 parts. Average time required to fall asleep, average hours of sleep per night, and ten questions based on sleep disturbance that were given a score of 1 (all the time) to 5 (none of the time). Based on the 12 questions, the following scales were calculated: sleep disturbance, snoring, awakening due to shortness of breath or headache, sleep adequacy, sleep somnolence, 9-item sleep item index, sleep quantity, and optimal sleep (not reported since it is a yes/no response). Each scale was given a score ranging from 1 (all the time) to 5 (none of the time), except for the 9-item sleep item index. Individual item scores of the 9-item sleep index were averaged and the total score ranged from 1 to 5. For all items reported, higher scores indicate an improvement in sleep disturbance.

    Measured: Baseline to Week 14 postdose

  6. Change From Baseline in the Hospital Anxiety & Depression Scale Following Administration With Mirogabalin or Placebo

    The Hospital Anxiety and Depression (HADS) scale consisted of 7 items to score depression (4-point scale: 0 to 3; where a score of 3 indicates highest depression levels [worse outcome]) and 7 items to score anxiety (4-point scale: 0 to 3; where score of 3 indicates highest anxiety levels [worse outcome]). The depression and anxiety subscales were calculated by summing the corresponding scores for 7 items. Negative scores indicate an improvement in depression and anxiety.

    Measured: Baseline to Week 14 postdose

  7. Change From Baseline in the Neuropathic Pain Symptom Inventory Score Following Administration With Mirogabalin or Placebo

    The Neuropathic Pain Symptom Inventory assessment was comprised of 4 distinct dimensions of neuropathic pain: spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia. Each dimension was scored on an 11-point scale from 0 (no pain) to 10 (the most intense pain imaginable) for reporting the mean intensity of each item of the dimension during the last 24 hours. The total score is the sum of each of the 4 dimensions of neuropathic pain and total score ranged from 0 to 40. Higher scores indicated worse outcome; negative values indicate an improvement.

    Measured: Baseline to Week 14 postdose

  8. Change From Baseline in the EuroQoL 5 Dimensions 5 Levels Following Administration With Mirogabalin or Placebo

    The EuroQoL 5 Dimensions 5 Levels (EuroQoL-5D-5L) questionnaire yielded a 5-scale profile of the participant's self-assessed quality of life in each of 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). These profiles were combined into an overall health utilities index, and a visual analog scale (VAS) that measured the participants' perceptions of overall health. EQ-5D-5L index scores range from -0.59 (worst health state) to 1 (best possible health state). EQ VAS scores range from 0 (worse imaginable health or worst outcome) to 100 (best imaginable health or best outcome). Higher scores for index value and VAS indicate better outcome.

    Measured: Baseline to Week 14 postdose

  9. Change From Baseline in the Spinal Cord Independence Measure Scores Following Administration With Mirogabalin or Placebo

    The Spinal Cord Independence Measure (SCIM) score assessed the participants' activities of daily living (ADL). The SCIM instrument yielded a profile of the participant's ADL in the following categories: total SCIM score (0 to 100), self-care (scored 0 to 20; with higher scores indicating better self care), respiration and sphincter management (0 to 40; with higher scores indicating better management), and mobility (0 to 40; with higher scores indicating better mobility). Overall higher scores indicated better outcomes.

    Measured: Baseline to Week 14 postdose

  10. Number of Participants Who Performed At Level or Below Level for Allodynia Following Administration With Mirogabalin or Placebo

    Study investigators performed the test for allodynia (at level, below level) using a scale assessing the presence (at level) or absence (below level) of allodynia. Testing usually requires an external stimulation of non-painful quality.

    Measured: Baseline to Week 14 postdose

  11. 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)

    Participants rated their present pain intensity on a visual analog scale of 0 (no pain) to 5 (most intense pain). Higher scores indicate worse outcome; negative changes in present pain intensity indicated an improvement in pain intensity.

    Measured: Baseline to Week 52 postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2019
  2. Study start12 Mar 2019
  3. Primary completion28 Dec 2020
  4. Study completion28 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03901352
Sponsor's protocol ID
DS5565-A-J314
Other IDs
194653
Status last verified
Oct 2024
First submitted
1 Apr 2019
Last updated
21 Oct 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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/

Publications

  • Hosomi K, Katayama Y, Sakoda H, Kikumori K, Kuroha M, Ushida T. Usefulness of Mirogabalin in Central Neuropathic Pain After Stroke: Post Hoc Analysis of a Phase 3 Study by Stroke Type and Location. Pain Ther. 2024 Oct;13(5):1151-1171. doi: 10.1007/s40122-024-00616-3. Epub 2024 Jul 4.

    PubMed 38963656

  • Ushida T, Katayama Y, Hiasa Y, Nishihara M, Tajima F, Katoh S, Tanaka H, Maeda T, Furusawa K, Kakehi Y, Kikumori K, Kuroha M. Long-Term Safety and Efficacy of Mirogabalin for Central Neuropathic Pain: A Multinational, Phase 3, 52-Week, Open-Label Study in Asia. Pain Ther. 2023 Aug;12(4):963-978. doi: 10.1007/s40122-023-00513-1. Epub 2023 Apr 28.

    PubMed 37115464

  • Ushida T, Katayama Y, Hiasa Y, Nishihara M, Tajima F, Katoh S, Tanaka H, Maeda T, Furusawa K, Richardson M, Kakehi Y, Kikumori K, Kuroha M. Mirogabalin for Central Neuropathic Pain After Spinal Cord Injury: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study in Asia. Neurology. 2023 Mar 14;100(11):e1193-e1206. doi: 10.1212/WNL.0000000000201709. Epub 2022 Dec 14.

    PubMed 36517235

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mirogabalin in people with Central Neuropathic Pain, run by Daiichi Sankyo Co., Ltd. at 118 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 118 sites in Japan, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in the Weekly Average Daily Pain Score (ADPS) at Week 14 Following Administration With Mirogabalin or Placebo (time frame: Baseline to Week 14 postdose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03901352, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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