A Randomized, Double Blind, Multi-center, Placebo-Controlled Exploratory Study of AS-3201 in Patients with Diabetic Sensorimotor Polyneuropathy
Phase 2
- Conditions
- Diabetic peripheral neuropathy
- Registration Number
- JPRN-jRCT2080221949
- Lead Sponsor
- Dainippon Sumitomo Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Patients with DPN who satisfy the following inclusion criteria
-Patients who have DPN symptoms, signs and abnormal nerve conduction on the basis of pre-defined criteria
-Outpatients
etc.
Exclusion Criteria
-Patients with known non diabetic causes of neuropathic symptoms
-Patients with focal or entrapment neuropathy
-Patients with a history of epilepsy or serious head injury
etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method erve conduction velocity<br>Last observation
- Secondary Outcome Measures
Name Time Method F-wave minimum latency, clinical symptoms and signs <br>Last observation