Evaluating the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy
Phase 2
Completed
- Conditions
- Mild to Moderate Diabetic Sensorimotor Polyneuropathy
- Interventions
- Drug: Placebo
- Registration Number
- NCT00927914
- Lead Sponsor
- Eisai Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 800
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Two placebo tablets, given orally, once daily, preferably in the morning with or without a light breakfast, for upto 24 months. Ranirestat 40 mg Ranirestat 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. Ranirestat 40 mg Placebo 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. Ranirestat 80 mg Ranirestat Two 80 mg Ranirestat tablets, given orally, once daily, preferably in the morning with or without a light breakfast, for upto 24 months.
- Primary Outcome Measures
Name Time Method Peroneal motor nerve conduction velocity: the mean of duplicate bilateral recordings made within 1-21 days of each other. 24 months
- Secondary Outcome Measures
Name Time Method Neuropathy total symptom score-6 via a self-administered questionnaire and vibration perception threshold recorded with a neurothesiometer. 24 months
Trial Locations
- Locations (1)
The Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States