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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00927914
First received: June 24, 2009
Last updated: June 5, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Mild to Moderate Diabetic Sensorimotor Polyneuropathy.
 Drug: Ranirestat 80 mg
Drug: Ranirestat 40 mg
Drug: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Peroneal motor nerve conduction velocity: the mean of duplicate bilateral recordings made within 1-21 days of each other. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neuropathy total symptom score-6 via a self-administered questionnaire and vibration perception threshold recorded with a neurothesiometer. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 800
Study Start Date: July 2009
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranirestat 80 mg Drug: Ranirestat 80 mg
Ranirestat 80 mg group (2x 40 mg tablets)
Experimental: Ranirestat 40 mg + Placebo Drug: Ranirestat 40 mg
Ranirestat 40 mg group (1x 40 mg tablet and 1x matching placebo)
Placebo Comparator: Placebo Drug: Placebo
Placebo group (2x placebo tablets)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00927914

Locations
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Roderick Junor Eisai Limited
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00927914     History of Changes
Other Study ID Numbers: AS3201-G000-291
Study First Received: June 24, 2009
Last Updated: June 5, 2013
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Canada: Health Canada

Additional relevant MeSH terms:
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013