Study to Assess the Efficacy, Safety and Tolerability of MT- 8554 in Subjects With Painful Diabetic Peripheral Neuropathy
NCT ID: NCT03172598
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
61 participants
INTERVENTIONAL
2017-07-25
2018-08-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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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 low dose
Capsule
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 middle dose
Capsule
MT-8554 high dose
Patients who meet eligibility criteria will be administered twice daily high dose of MT-8554 during the treatment period.
MT-8554 high dose
Capsule
MT-8554, then placebo
The study participants will receive MT-8554 (TBD mg) in the first phase, followed by placebo in the second phase
MT-8554 low dose
Capsule
MT-8554 middle dose
Capsule
MT-8554 high dose
Capsule
Placebo
Capsule
Placebo, then MT-8554
The study participants will receive placebo in the first phase, followed by MT-8554 (TBD mg) in the second phase
MT-8554 low dose
Capsule
MT-8554 middle dose
Capsule
MT-8554 high dose
Capsule
Placebo
Capsule
Interventions
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MT-8554 low dose
Capsule
MT-8554 middle dose
Capsule
MT-8554 high dose
Capsule
Placebo
Capsule
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Unstable or uncontrolled diabetes
* Clinically significant 12-lead ECG abnormalities
18 Years
ALL
No
Sponsors
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Tanabe Pharma Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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General Manager
Role: STUDY_DIRECTOR
Tanabe Pharma Europe Ltd
Locations
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Investigational center
City Name, , Germany
Investigational center
City Name, , Hungary
Investigational center
City Name, , Poland
Countries
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Other Identifiers
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MT-8554-E06
Identifier Type: -
Identifier Source: org_study_id