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Home > "L" Clinical Trials Conditions > Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy  Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy
Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy
For Condition: Diabetic Polyneuropathy
Status: No longer recruiting
Sponsor(s): The Institute for Diabetes Discovery, LLC ,
Synopsis: This clinical trial is to determine an effective dosage and to study the safety of an investigational drug -lidorestat (IDD-676)- which is intended to stop or slow the progression of diabetic peripheral neuropathy.
Details: Diabetic peripheral neuropathy is one of the most important and serious complications of diabetes. It can cause pain and loss of sensation, loss of mobility and lead to chronic wounds and amputations. Studies indicate 50% or more of people who have diabetes now have or will have significant neuropathy. Several currently marketed or investigational drugs are available to treat the painful symptoms of diabetic peripheral neuropathy, but there are no approved drugs that have been shown to prevent or slow the progression of the neuropathy itself. The current clinical trial is an early phase II study designed to investigate the safety of the investigational drug lidorestat (IDD-676) and to determine the effect of various dose levels on important biochemical processes in the pathology of diabetic neuropathy. Participants who enter and complete this study will, if the agent is successful, help in a very important way to bring an effective treatment from research laboratories to widespread availability for treatment. On the basis of the results of this study, large scale studies will be undertaken to support application for product registration and distribution in the U.S. and other countries throughout the world.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: Inclusion: - Clinical diagnosis of Type 1 or Type II diabetes with mild to moderate diabetic peripheral neuropathy. - Healthy status except for diabetes - Ability to make frequent clinic visits over a 7-month period. - Willingness and ability to understand and sign consent form. Exclusion: - Pregnancy or breast feeding - Presence of uncontrolled hypertension - History or presence of significant kidney or liver disease.
Total Enrollment:
Location and Contact Information:
Scottsdale Medical Specialists
Scottsdale, Arizona,
United States
Toronto General Hospital, University Health Network
Toronto, Ontario,
Canada
University of Oklahoma
Oklahoma City, Oklahoma,
United States
Johns Hopkins University - School of Medicine
Baltimore, Maryland, 21205
United States
Radiant Research
Gainesville, Florida, 32605
United States
University of Texas, Southwest Medical Center
Dallas, Texas,
United States
Hospital de L'Enfant-Jesus
Quebec City, Quebec,
Canada
Brody School of Medicine, East Carolina University
Greenville, North Carolina,
United States
Diabetes & Glandular Disease Clinic
San Antonio, Texas,
United States
Diabetes & Endocrine Associates
La Jolla, California, 92037
United States
University of Miami, Dept. of Diabetes, Endocrinology & Metabolism
Miami, Florida, 33136
United States
Centre de Recherche
Laval, Quebec,
Canada
Glendale Adventist Medical Center
Glendale, California, 91206
United States
Marin Endocrinology Associates
Greenbrae, California,
United States
Additional Information:
Study ID Numbers: 676/US/2-01;
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043797
Other Diabetic Polyneuropathy Studies:
1. Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy
Related Studies:
Other Diabetic Polyneuropathy Clinical Trials
Other California Clinical Trials
Other Greenbrae Clinical Trials
Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy
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