NCT00307749

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

First QC Date

March 27, 2006

Last Update Submit

December 26, 2007

Conditions

Diabetic Polyneuropathy

Keywords

NeuropathyNerve Conduction

Outcome Measures

Primary Outcomes (1)

  • Nerve Conduction Studies

    Day 1, Week 24

Secondary Outcomes (4)

  • 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

Study Arms (4)

1

PLACEBO COMPARATOR
Drug: Placebo

2

EXPERIMENTAL
Drug: MCC-257

3

EXPERIMENTAL
Drug: MCC-257

4

EXPERIMENTAL
Drug: MCC-257

Interventions

PlaceboDRUG

once daily for 24 weeks

1
MCC-257DRUG

20mg, once daily for 24 weeks

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

MCC-257

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Professor

    Information at Mitsubishi Pharma America

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 27, 2006

First Posted

March 28, 2006

Study Start

March 1, 2006

Study Completion

August 1, 2007

Last Updated

December 28, 2007

Record last verified: 2007-12