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Trial record 1 of 1 for:    MT-8554-E06
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Study to Assess the Efficacy, Safety and Tolerability of MT- 8554 in Subjects With Painful Diabetic Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT03172598
Recruitment Status : Completed
First Posted : June 1, 2017
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Painful Diabetic Peripheral Neuropathy Drug: MT-8554 low dose Drug: MT-8554 middle dose Drug: MT-8554 high dose Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIa, Multi-Centre, Randomised, Double-Blind, Cross-Over, Placebo-Controlled Study to Assess the Efficacy, Safety and Tolerability of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy Incorporating an Open Label Pilot Arm
Actual Study Start Date : July 25, 2017
Actual Primary Completion Date : August 8, 2018
Actual Study Completion Date : August 8, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MT-8554 low dose
Patients who meet eligibility criteria will be administered twice daily low dose of MT-8554 during the treatment period.
Drug: MT-8554 low dose
Capsule

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

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

Experimental: MT-8554, then placebo
The study participants will receive MT-8554 (TBD mg) in the first phase, followed by placebo in the second phase
Drug: MT-8554 low dose
Capsule

Drug: MT-8554 middle dose
Capsule

Drug: MT-8554 high dose
Capsule

Drug: Placebo
Capsule

Experimental: Placebo, then MT-8554
The study participants will receive placebo in the first phase, followed by MT-8554 (TBD mg) in the second phase
Drug: MT-8554 low dose
Capsule

Drug: MT-8554 middle dose
Capsule

Drug: MT-8554 high dose
Capsule

Drug: Placebo
Capsule




Primary Outcome Measures :
  1. Safety and Tolerability as measured by vital signs and Adverse Events [ Time Frame: Up to Day 22 ]
    Number of participants with potentially clinically important vital sign measurements or tolerability issues

  2. Efficacy as measured by reduction in pain using a numerical rating scale. [ Time Frame: Up to Day 49 ]
    Pain reduction using an 11-point numerical rating scale


Secondary Outcome Measures :
  1. Number of subjects with electrocardiogram (ECG) findings of potential clinical importance [ Time Frame: Up to Day 49 ]
    Number of participants with potentially clinically important ECG findings

  2. Plasma concentration of MT-8554 [ Time Frame: Up to Day 49 ]
    Maximum Observed Plasma Concentration (Cmax)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172598


Locations
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Germany
Investigational center
City Name, Germany
Hungary
Investigational center
City Name, Hungary
Poland
Investigational center
City Name, Poland
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Study Director: General Manager Mitsubishi Tanabe Pharma Europe Ltd

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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT03172598     History of Changes
Other Study ID Numbers: MT-8554-E06
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Pain
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases