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A Study to Investigate the Safety, Tolerability and Efficacy of Multiple Doses of MT-8554 in Subjects with Painful Diabetic Peripheral Neuropathy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-8554 low dose | Experimental | Patients who meet eligibility criteria will be administered twice daily low dose of MT-8554 during the treatment period. |
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| MT-8554 middle dose | Experimental | Patients who meet eligibility criteria will be administered twice daily middle dose of MT-8554 during the treatment period. |
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| MT-8554 high dose | Experimental | Patients who meet eligibility criteria will be administered twice daily high dose of MT-8554 during the treatment period. |
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| MT-8554, then placebo | Experimental | The study participants will receive MT-8554 (TBD mg) in the first phase, followed by placebo in the second phase |
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| Placebo, then MT-8554 | Experimental | The study participants will receive placebo in the first phase, followed by MT-8554 (TBD mg) in the second phase |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-8554 low dose | Drug | Capsule |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability as measured by vital signs and Adverse Events | Number of participants with potentially clinically important vital sign measurements or tolerability issues | Up to Day 22 |
| Efficacy as measured by reduction in pain using a numerical rating scale. | Pain reduction using an 11-point numerical rating scale | Up to Day 49 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with electrocardiogram (ECG) findings of potential clinical importance | Number of participants with potentially clinically important ECG findings | Up to Day 49 |
| Plasma concentration of MT-8554 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| General Manager | Tanabe Pharma Europe Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational center | City Name | Germany | ||||
| Investigational center |
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| MT-8554 middle dose | Drug | Capsule |
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| MT-8554 high dose | Drug | Capsule |
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| Placebo | Drug | Capsule |
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Maximum Observed Plasma Concentration (Cmax)
| Up to Day 49 |
| City Name |
| Hungary |
| Investigational center | City Name | Poland |