Clinical Trials List
Protocol NumberDS5565-A-J314
NCT Number(ClinicalTrials.gov Identfier)NCT03901352
2019-06-01 - 2021-04-12
Phase III
Terminated4
ICD-10M79.2
Neuralgia and neuritis, unspecified
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
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Trial Applicant
CMIC Asia-Pacific
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Sponsor
Daiichi Sankyo Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 陳靖倫 Division of Rehabilitation Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Central Neuropathic Pain
Objectives
[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).
Test Drug
DS-5565 (Mirogabalin)
Active Ingredient
[(1R,5S,6S)-6-(Aminomethyl)-3-ethylbicyclo[3.2.0]hept-3-en-6-yl] acetic acid monobenzenesulfonate
Dosage Form
tablet
Dosage
2.5/ 5/ 7.5/ 10/ 15
Endpoints
Primary Outcome Measures :
Average Daily Pain Score (ADPS) [ Time Frame: Baseline to Week 14 ]
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.
Secondary Outcome Measures :
Average Daily Pain Score (ADPS) Response Rate [ Time Frame: at Week 14 ]
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.
Pain Intensity Score Using the Short-Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: Baseline to Week 14 ]
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)
Patient Global Impression of Change [ Time Frame: at Week 14 ]
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.
Average Daily Sleep Interference score (ADSIS) [ Time Frame: Baseline to Week 14 ]
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.
Average Daily Pain Score (ADPS) [ Time Frame: Baseline to Week 14 ]
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.
Secondary Outcome Measures :
Average Daily Pain Score (ADPS) Response Rate [ Time Frame: at Week 14 ]
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.
Pain Intensity Score Using the Short-Form McGill Pain Questionnaire (SF-MPQ) [ Time Frame: Baseline to Week 14 ]
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)
Patient Global Impression of Change [ Time Frame: at Week 14 ]
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.
Average Daily Sleep Interference score (ADSIS) [ Time Frame: Baseline to Week 14 ]
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.
Inclution Criteria
(Double-Blind Phase)
1. Age ≥ 20 years at informed consent
2. Able to give informed consent for the study participation, understand procedures
of this study, and complete patient-reported questionnaires adequately
3. SCI due to trauma (eg, turnover, fall, traffic accident, sports accident)
4. C4-T12 spinal cord injury identified on MRI
5. American Spinal Injury Association (ASIA) impairment scale A, B, C, or D
6. NeP region expressed at level and/or below level of spinal cord injury
7. ≥ 6 months after SCI at screening
8. Stable CNePSCI at least for 3 months prior to screening
9. At screening, a pain scale of ≥ 40 mm on VAS of SF-MPQ
10. At randomization, a pain scale of ≥ 40 mm on VAS of SF-MPQ, and completion
of at least 4 days of daily pain diaries with an ADPS of ≥ 4 over the past 7 days
on the 11-point Numerical Rating Scale (NRS)
1. Age ≥ 20 years at informed consent
2. Able to give informed consent for the study participation, understand procedures
of this study, and complete patient-reported questionnaires adequately
3. SCI due to trauma (eg, turnover, fall, traffic accident, sports accident)
4. C4-T12 spinal cord injury identified on MRI
5. American Spinal Injury Association (ASIA) impairment scale A, B, C, or D
6. NeP region expressed at level and/or below level of spinal cord injury
7. ≥ 6 months after SCI at screening
8. Stable CNePSCI at least for 3 months prior to screening
9. At screening, a pain scale of ≥ 40 mm on VAS of SF-MPQ
10. At randomization, a pain scale of ≥ 40 mm on VAS of SF-MPQ, and completion
of at least 4 days of daily pain diaries with an ADPS of ≥ 4 over the past 7 days
on the 11-point Numerical Rating Scale (NRS)
Exclusion Criteria
(Double-Blind Phase)
1. On any one day during the observation period, pain score of 10 on a scale of 0 (no
pain) to 10 (worst possible pain)
2. Other severe pain at screening or randomization, unrelated to CNePSCI, that may
confound the assessment of CNePSCI
3. Neurologic disorders at screening or randomization, unrelated to CNePSCI, that
may confound the assessment of CNePSCI
4. Major psychiatric disorders within 1 year prior to screening
5. Patient who has secondary-gain from CNePSCI (eg, legal dispute or settlement
negotiations) at screening or randomization
6. SCI due to suicidal behavior
7. Patient who blames the third party for his/her spinal cord injury, in the case of
spinal cord injury due to the third party act (Those patients can rarely overcome
the pain due to the psychiatric factor)
8. Previous administration of pregabalin ≥ 300 mg/day for subjects with CLcr (using
the Cockcroft-Gault) ≥ 60 mL/min or ≥ pregabalin 150 mg/day for subjects with
CLcr 30 to < 60 mL/min for at least 4 weeks, declared lack of effect
9. Previous administration of gabapentin ≥ 1200 mg/day for subjects with CLcr
≥ 60 mL/min or gabapentin ≥ 600 mg/day for subjects with CLcr 30 to < 60, for at
least 4 weeks, declared lack of effect
10. Use of mirogabalin, pregabalin, or gabapentin within 28 days prior to screening
11. Use of strong opioids for analgesic of CNePSCI within 3 months prior to
screening
12. CLcr (using the Cockcroft-Gault equation) < 30 mL/min at screening
13. Malignancy other than basal cell carcinoma within the past 2 years prior to
screening
14. Clinically significant unstable endocrine (eg, diabetes mellitus), neurologic,
ophthalmologic, hepatobiliary, respiratory, hematologic illness, or cardiovascular
disease (eg, uncontrolled cardiac arrhythmia, or myocardial infarction) at
screening or randomization
15. Clinically significant findings on electrocardiogram (ECG) at screening
16. History of pernicious anemia, untreated hypothyroidism, or human
immunodeficiency virus infection
17. Pregnancy, potential pregnancy, breast feeding, or subject unwilling to take
reliable contraceptive measures during the study or for 4 weeks after study
completion
18. Known hypersensitivity to mirogabalin, pregabalin, or gabapentin
19. Participation in another clinical study, either currently or within 30 days prior to
providing of informed consent
20. Experience of participating mirogabalin clinical study and receiving
investigational product
21. Abuse of illicit drugs or alcohol history
22. Response of “yes” to any of the questions on the C-SSRS at screening or
randomization in relation to events occurring within the past 12 months
23. At screening, clinical laboratory values exceeding limits listed in Table 4.1
24. The subject who is considered inappropriate for the study at the discretion of the
investigator or sub-investigator
1. On any one day during the observation period, pain score of 10 on a scale of 0 (no
pain) to 10 (worst possible pain)
2. Other severe pain at screening or randomization, unrelated to CNePSCI, that may
confound the assessment of CNePSCI
3. Neurologic disorders at screening or randomization, unrelated to CNePSCI, that
may confound the assessment of CNePSCI
4. Major psychiatric disorders within 1 year prior to screening
5. Patient who has secondary-gain from CNePSCI (eg, legal dispute or settlement
negotiations) at screening or randomization
6. SCI due to suicidal behavior
7. Patient who blames the third party for his/her spinal cord injury, in the case of
spinal cord injury due to the third party act (Those patients can rarely overcome
the pain due to the psychiatric factor)
8. Previous administration of pregabalin ≥ 300 mg/day for subjects with CLcr (using
the Cockcroft-Gault) ≥ 60 mL/min or ≥ pregabalin 150 mg/day for subjects with
CLcr 30 to < 60 mL/min for at least 4 weeks, declared lack of effect
9. Previous administration of gabapentin ≥ 1200 mg/day for subjects with CLcr
≥ 60 mL/min or gabapentin ≥ 600 mg/day for subjects with CLcr 30 to < 60, for at
least 4 weeks, declared lack of effect
10. Use of mirogabalin, pregabalin, or gabapentin within 28 days prior to screening
11. Use of strong opioids for analgesic of CNePSCI within 3 months prior to
screening
12. CLcr (using the Cockcroft-Gault equation) < 30 mL/min at screening
13. Malignancy other than basal cell carcinoma within the past 2 years prior to
screening
14. Clinically significant unstable endocrine (eg, diabetes mellitus), neurologic,
ophthalmologic, hepatobiliary, respiratory, hematologic illness, or cardiovascular
disease (eg, uncontrolled cardiac arrhythmia, or myocardial infarction) at
screening or randomization
15. Clinically significant findings on electrocardiogram (ECG) at screening
16. History of pernicious anemia, untreated hypothyroidism, or human
immunodeficiency virus infection
17. Pregnancy, potential pregnancy, breast feeding, or subject unwilling to take
reliable contraceptive measures during the study or for 4 weeks after study
completion
18. Known hypersensitivity to mirogabalin, pregabalin, or gabapentin
19. Participation in another clinical study, either currently or within 30 days prior to
providing of informed consent
20. Experience of participating mirogabalin clinical study and receiving
investigational product
21. Abuse of illicit drugs or alcohol history
22. Response of “yes” to any of the questions on the C-SSRS at screening or
randomization in relation to events occurring within the past 12 months
23. At screening, clinical laboratory values exceeding limits listed in Table 4.1
24. The subject who is considered inappropriate for the study at the discretion of the
investigator or sub-investigator
The Estimated Number of Participants
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Taiwan
32 participants
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Global
454 participants
