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

Phase 2

Completed

• Conditions: Diabetic Polyneuropathy
• Interventions: Drug: MCC-257; Drug: Placebo

• Registration Number: NCT00307749
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

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

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 Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-27
• Study First Submitted QC: 2006-03-27
• Study First Posted: 2006-03-28
• Study Completion: 2007-08
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-26
• Last Update Posted: 2007-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	MCC-257	-
4	MCC-257	-
1	Placebo	-
2	MCC-257	-

Primary Outcome Measures

Name	Time	Method
Nerve Conduction Studies	Day 1, Week 24

Secondary Outcome Measures

Name	Time	Method
Nerve fiber density	Day 1, Week 24
QST	Day 1, Week 12, Week 24
Symptom	Day 1, Week 12, Week 24
Clinical Global Impression	Week 12, Week 24