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

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.

Timeline

Start

2009-07

Primary completion

2013-01

Completion

2013-02

Outcome

Missed primary endpoint

paper The mean improvement from baseline at 24 months was +0.49, +0.95, and +0.90 m/s for placebo, ranirestat 40 mg and 80 mg, respectively (NS). PMID 26313450 ↗

paper Ranirestat was well tolerated and improved PMNCV, but did not achieve any efficacy endpoints. PMID 26313450 ↗

Publications

• Polydefkis M, Arezzo J, Nash M, Bril V, Shaibani A, Gordon RJ, Bradshaw KL, Junor RW; Ranirestat Study Group. Safety and efficacy of ranirestat in patients with mild-to-moderate diabetic sensorimotor polyneuropathy. J Peripher Nerv Syst. 2015 Dec;20(4):363-71. doi: 10.1111/jns.12138.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ranirestat	Small molecule	40 mg	Oral
Subject	Ranirestat	Small molecule	80 mg	Oral

Indications