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

NCT ID: NCT00927914

Last Updated: 2019-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2013-02-28

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.

Conditions

Mild to Moderate Diabetic Sensorimotor Polyneuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ranirestat 80 mg

Two 80 mg Ranirestat tablets, given orally, once daily, preferably in the morning with or without a light breakfast, for upto 24 months.

Group Type: EXPERIMENTAL

Ranirestat

Intervention Type: DRUG

Ranirestat 40 mg tablets

Ranirestat 40 mg

One 40 mg tablet of Ranirestat and a matching placebo, given orally, once daily, preferably in the morning with or without a light breakfast, for upto 24 months.

Group Type: EXPERIMENTAL

Ranirestat

Intervention Type: DRUG

Ranirestat 40 mg tablets

Placebo

Intervention Type: DRUG

Placebo tablets

Placebo

Two placebo tablets, given orally, once daily, preferably in the morning with or without a light breakfast, for upto 24 months.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablets

Interventions

Ranirestat

Ranirestat 40 mg tablets

Intervention Type: DRUG

Placebo

Placebo tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects with Type 1 or Type 2, insulin-dependent or non insulin-dependent diabetes mellitus.
• Subjects with a history of distal symmetric polyneuropathy, secondary to diabetes, diagnosed in accordance with the American Academy of Neurology criteria.
• Female subjects, who are of non-reproductive potential (>=12 months post-menopausal or surgically sterile) or who are using adequate contraception which includes abstinence or double barrier methods (diaphragm and condom with spermicidal cream, intrauterine device and condom with spermicidal cream). Male subjects with partners of child-bearing potential must also use adequate contraception.
• Subjects must be able to read, understand, and provide written informed consent before enrolling in the study at screening.

Exclusion Criteria

• History of diabetic foot ulcers or lower extremity amputation.
• Diabetic amyotrophy or non-diabetic cause of lower limb neuropathy/neuropathic symptoms.
• Clinically significant illness which, in the opinion of the investigator, would compromise a subject's suitability to participate in the study for reasons of safety or would confound the efficacy assessments.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roderick Junor

Role: STUDY_DIRECTOR

Eisai Limited

Locations

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26313450 (View on PubMed)

Other Identifiers

2008-002843-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AS3201-G000-291

Identifier Type: -

Identifier Source: org_study_id