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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00307749

Enrollment

420

Registered

2006-03-28

Start date

2006-03-31

Completion date

2007-08-31

Last updated

2007-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Polyneuropathy

Keywords

Neuropathy, Nerve Conduction

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.

Interventions

DRUGPlacebo

once daily for 24 weeks

DRUGMCC-257

20mg, once daily for 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Nerve Conduction Studies	Day 1, Week 24

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026