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A Randomized, Double Blind, Multi-center, Placebo-Controlled Exploratory Study of AS-3201 in Patients with Diabetic Sensorimotor Polyneuropathy

A Randomized, Double Blind, Multi-center, Placebo-Controlled Exploratory Study of AS-3201 in Patients with Diabetic Sensorimotor Polyneuropathy [Phase II]

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221949
Enrollment
60
Registered
2012-10-24
Start date
2012-10-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic peripheral neuropathy

Interventions

investigational material(s) Generic name etc : AS-3201 (ranirestat) INN of investigational material : Therapeutic category code : 129 Other agents affecting peripheral nervous system Dosage and Admin

Sponsors

Dainippon Sumitomo Pharma Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Nerve conduction velocity Last observation

Secondary

MeasureTime frame
F-wave minimum latency, clinical symptoms and signs Last observation

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026