Clinical Trial: Evaluating the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 2-year, Randomized, Double-blind, Placebo-controlled, Multi-center, Phase II-III Study to Evaluate the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor

Brief Summary: The purpose of this study is to determine the effect of 40 mg and 80 mg ranirestat on peroneal motor nerve conduction velocity relative to placebo in subjects with mild to moderate diabetic sensorimotor polyneuropathy.

Detailed Summary:
Sponsor: Eisai Inc.

Current Primary Outcome: Peroneal motor nerve conduction velocity: the mean of duplicate bilateral recordings made within 1-21 days of each other. [ Time Frame: 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Neuropathy total symptom score-6 via a self-administered questionnaire and vibration perception threshold recorded with a neurothesiometer. [ Time Frame: 24 months ]

Original Secondary Outcome: Same as current

Information By: Eisai Inc.

Dates:
Date Received: June 24, 2009
Date Started: July 2009
Date Completion:
Last Updated: November 17, 2015
Last Verified: November 2015