Study to Assess the Efficacy, Safety and Tolerability of MT- 8554 in Subjects With Painful Diabetic Peripheral Neuropathy
Phase 2
Completed
- Conditions
- Painful Diabetic Peripheral Neuropathy
- Interventions
- Drug: MT-8554 middle doseDrug: MT-8554 low doseDrug: MT-8554 high doseDrug: Placebo
- Registration Number
- NCT03172598
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief Summary
A Study to Investigate the Safety, Tolerability and Efficacy of Multiple Doses of MT-8554 in Subjects with Painful Diabetic Peripheral Neuropathy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
Inclusion Criteria
- Male subjects and female subjects aged ≥18 years
- Subjects who have a history of pain at least 6 months and ≤7 years attributed to diabetic peripheral neuropathy
- A body mass index ranging from 18 to 45 kg/m2
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Exclusion Criteria
- Subjects who have participated in a clinical study of any IMP (other than placebo) within 12 weeks (from last administration) prior to screening or who are currently participation in another clinical study
- Unstable or uncontrolled diabetes
- Clinically significant 12-lead ECG abnormalities
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo, then MT-8554 MT-8554 high dose The study participants will receive placebo in the first phase, followed by MT-8554 (TBD mg) in the second phase MT-8554 middle dose MT-8554 middle dose Patients who meet eligibility criteria will be administered twice daily middle dose of MT-8554 during the treatment period. MT-8554, then placebo MT-8554 middle dose The study participants will receive MT-8554 (TBD mg) in the first phase, followed by placebo in the second phase MT-8554, then placebo Placebo The study participants will receive MT-8554 (TBD mg) in the first phase, followed by placebo in the second phase Placebo, then MT-8554 MT-8554 low dose The study participants will receive placebo in the first phase, followed by MT-8554 (TBD mg) in the second phase MT-8554, then placebo MT-8554 low dose The study participants will receive MT-8554 (TBD mg) in the first phase, followed by placebo in the second phase MT-8554, then placebo MT-8554 high dose The study participants will receive MT-8554 (TBD mg) in the first phase, followed by placebo in the second phase Placebo, then MT-8554 MT-8554 middle dose The study participants will receive placebo in the first phase, followed by MT-8554 (TBD mg) in the second phase MT-8554 low dose MT-8554 low dose Patients who meet eligibility criteria will be administered twice daily low dose of MT-8554 during the treatment period. MT-8554 high dose MT-8554 high dose Patients who meet eligibility criteria will be administered twice daily high dose of MT-8554 during the treatment period. Placebo, then MT-8554 Placebo The study participants will receive placebo in the first phase, followed by MT-8554 (TBD mg) in the second phase
- Primary Outcome Measures
Name Time Method Efficacy as measured by reduction in pain using a numerical rating scale. Up to Day 49 Pain reduction using an 11-point numerical rating scale
Safety and Tolerability as measured by vital signs and Adverse Events Up to Day 22 Number of participants with potentially clinically important vital sign measurements or tolerability issues
- Secondary Outcome Measures
Name Time Method Number of subjects with electrocardiogram (ECG) findings of potential clinical importance Up to Day 49 Number of participants with potentially clinically important ECG findings
Plasma concentration of MT-8554 Up to Day 49 Maximum Observed Plasma Concentration (Cmax)
Trial Locations
- Locations (1)
Investigational center
🇵🇱City Name, Poland