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

Primary Purpose

Mild to Moderate Diabetic Sensorimotor Polyneuropathy

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Ranirestat

Placebo

About this trial

This is an interventional treatment trial for Mild to Moderate Diabetic Sensorimotor Polyneuropathy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Johns Hopkins Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Ranirestat 80 mg

Ranirestat 40 mg

Placebo

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

Peroneal motor nerve conduction velocity: the mean of duplicate bilateral recordings made within 1-21 days of each other.

Secondary Outcome Measures

Neuropathy total symptom score-6 via a self-administered questionnaire and vibration perception threshold recorded with a neurothesiometer.

Full Information

NCT ID

NCT00927914

First Posted

June 24, 2009

Last Updated

February 18, 2019

Sponsor

Eisai Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00927914

Brief Title

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

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 Polyneuropathy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

July 2009 (Actual)

Primary Completion Date

January 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eisai Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild to Moderate Diabetic Sensorimotor Polyneuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

800 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ranirestat 80 mg

Arm Type

Experimental

Arm Description

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

Arm Title

Ranirestat 40 mg

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ranirestat

Intervention Description

Ranirestat 40 mg tablets

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo tablets

Primary Outcome Measure Information:

Title

Peroneal motor nerve conduction velocity: the mean of duplicate bilateral recordings made within 1-21 days of each other.

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Neuropathy total symptom score-6 via a self-administered questionnaire and vibration perception threshold recorded with a neurothesiometer.

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Roderick Junor

Organizational Affiliation

Eisai Limited

Official's Role

Study Director

Facility Information:

Facility Name

The Johns Hopkins Hospital

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26313450

Citation

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.

Results Reference

derived

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

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