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

• Sponsor: Mitsubishi Tanabe Pharma Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00307749
• Collaborator: (none)
• Enrollment: 420
• Arms: 4
• Duration (Months): 17

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diabetic Polyneuropathy	Drug: Placebo; Drug: MCC-257; Drug: MCC-257; Drug: MCC-257	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 420 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Mar 1, 2006
• Actual Study Completion Date: Aug 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Nerve Conduction Studies [Day 1, Week 24]

Secondary Outcome Measures

1. Nerve fiber density [Day 1, Week 24]

2. QST [Day 1, Week 12, Week 24]

3. Symptom [Day 1, Week 12, Week 24]

4. Clinical Global Impression [Week 12, Week 24]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Mitsubishi Tanabe Pharma Corporation

Investigators

• Principal Investigator: Professor, Information at Mitsubishi Pharma America

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00307749
• Other Study ID Numbers: MCC-257-A03
• First Posted: Mar 28, 2006
• Last Update Posted: Dec 28, 2007
• Last Verified: Dec 1, 2007

• Keywords provided by , ,: Neuropathy; Nerve Conduction
• Additional relevant MeSH terms: Polyneuropathies; Diabetic Neuropathies

Study Results

No Results Posted as of Dec 28, 2007