Safety and Efficacy of MCC-257 in the Treatment of Diabetic Polyneuropathy

December 26, 2007 updated by: Mitsubishi Tanabe Pharma Corporation

A Phase II, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Finding Study to Evaluate the Efficacy and Safety of 20mg, 40mg and 80mg of MCC-257 in Patients With Mild to Moderate Diabetic Polyneuropathy

The primary objectives of the study are to evaluate the efficacy and safety of three doses of MCC-257 in patients with mild to moderate diabetic polyneuropathy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will use a double-blind, randomized, placebo-controlled, fixed-dose, parallel-group design. Patients will be randomized equally to 1 of 4 treatment groups: MCC-257 20 mg, MCC-257 40 mg, MCC-257 80 mg, or placebo, given once daily for 24 weeks. The study will consist of 2 periods: 1) a screening period of up to 21 days prior to baseline, including a formal screening visit; and 2) a 24-week treatment period, during which patients will take the study treatment, and have various assessments performed during 4 visits.

Study Type

Interventional

Enrollment (Actual)

420

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient is male or female, 18-70 years of age
  • The patient has either type 1 or type 2 diabetes
  • The patient has mild to moderate diabetic neuropathy
  • The patient is free from other clinically significant illness or disease, as determined by medical history, physical examination, laboratory evaluations, and other safety tests

Exclusion Criteria:

  • Being treated with anticoagulants other than aspirin, such as warfarin, digoxin, Plavix
  • BMI>40
  • A significant disorder or a condition other than diabetes that can cause symptoms or physical conditions that mimic peripheral neuropathy or interfere with cognition
  • Any proximal neuropathy, clinically evident nerve entrapment, or any focal trauma potentially affecting nerve function
  • Women of childbearing potential who do not refrain from sexual activity or use adequate contraception
  • Pregnant or lactating women
  • An ALT or AST value >2X upper limit of normal (ULN)
  • Clinically significant cardiovascular disease within the last six (6) months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: MCC-257
20mg, once daily for 24 weeks
Drug: MCC-257
40mg, once daily for 24 weeks
Drug: MCC-257
80mg, once daily for 24 weeks
Placebo Comparator: 1
Drug: Placebo
once daily for 24 weeks
Experimental: 3
Drug: MCC-257
20mg, once daily for 24 weeks
Drug: MCC-257
40mg, once daily for 24 weeks
Drug: MCC-257
80mg, once daily for 24 weeks
Experimental: 4
Drug: MCC-257
20mg, once daily for 24 weeks
Drug: MCC-257
40mg, once daily for 24 weeks
Drug: MCC-257
80mg, once daily for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Nerve Conduction Studies
Time Frame: Day 1, Week 24
Day 1, Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Nerve fiber density
Time Frame: Day 1, Week 24
Day 1, Week 24
QST
Time Frame: Day 1, Week 12, Week 24
Day 1, Week 12, Week 24
Symptom
Time Frame: Day 1, Week 12, Week 24
Day 1, Week 12, Week 24
Clinical Global Impression
Time Frame: Week 12, Week 24
Week 12, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Investigators

  • Principal Investigator: Professor, Information at Mitsubishi Pharma America

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

March 27, 2006

First Submitted That Met QC Criteria

March 27, 2006

First Posted (Estimate)

March 28, 2006

Study Record Updates

Last Update Posted (Estimate)

December 28, 2007

Last Update Submitted That Met QC Criteria

December 26, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-257-A03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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