Study to Assess the Efficacy, Safety and Tolerability of MT- 8554 in Subjects With Painful Diabetic Peripheral Neuropathy

Tanabe Pharma Corporation

Status and phase: Completed; Phase 2

Conditions: Painful Diabetic Peripheral Neuropathy

Treatments: Drug: Placebo; Drug: MT-8554 middle dose; Drug: MT-8554 low dose; Drug: MT-8554 high dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT03172598

MT-8554-E06

Details and patient eligibility

About

A Study to Investigate the Safety, Tolerability and Efficacy of Multiple Doses of MT-8554 in Subjects with Painful Diabetic Peripheral Neuropathy

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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61 participants in 5 patient groups

MT-8554 low dose

Experimental group

Description:

Patients who meet eligibility criteria will be administered twice daily low dose of MT-8554 during the treatment period.

Treatment:

Drug: MT-8554 low dose

MT-8554 middle dose

Experimental group

Description:

Patients who meet eligibility criteria will be administered twice daily middle dose of MT-8554 during the treatment period.

Treatment:

Drug: MT-8554 middle dose

MT-8554 high dose

Experimental group

Description:

Patients who meet eligibility criteria will be administered twice daily high dose of MT-8554 during the treatment period.

Treatment:

Drug: MT-8554 high dose

MT-8554, then placebo

Experimental group

Description:

The study participants will receive MT-8554 (TBD mg) in the first phase, followed by placebo in the second phase

Treatment:

Drug: MT-8554 high dose

Drug: MT-8554 low dose

Drug: Placebo

Drug: MT-8554 middle dose

Placebo, then MT-8554

Experimental group

Description:

The study participants will receive placebo in the first phase, followed by MT-8554 (TBD mg) in the second phase

Treatment:

Drug: MT-8554 high dose

Drug: MT-8554 low dose

Drug: Placebo

Drug: MT-8554 middle dose