NCT00927914

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

February 21, 2019

Status Verified

November 1, 2015

Enrollment Period

3.5 years

First QC Date

June 24, 2009

Last Update Submit

February 18, 2019

Conditions

Mild to Moderate Diabetic Sensorimotor Polyneuropathy

Outcome Measures

Primary Outcomes (1)

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

    24 months

Secondary Outcomes (1)

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

    24 months

Study Arms (3)

Ranirestat 80 mg

EXPERIMENTAL

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

Drug: Ranirestat

Ranirestat 40 mg

EXPERIMENTAL

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.

Drug: RanirestatDrug: Placebo

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

RanirestatDRUG

Ranirestat 40 mg tablets

Ranirestat 40 mgRanirestat 80 mg
PlaceboDRUG

Placebo tablets

PlaceboRanirestat 40 mg

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21231, United States

Location

Related Publications (1)

  • 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.

    PMID: 26313450DERIVED

MeSH Terms

Interventions

ranirestat

Study Officials

  • Roderick Junor

    Eisai Limited

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2009

First Posted

June 25, 2009

Study Start

July 1, 2009

Primary Completion

January 1, 2013

Study Completion

February 1, 2013

Last Updated

February 21, 2019

Record last verified: 2015-11

Locations

US(1)