A multicenter, randomized, double-blind, placebo-controlled, parallel-group, confirmatory study of AS-3201 in patients with diabetic peripheral neuropathy (Phase III)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221660

Enrollment

520

Registered

2011-11-29

Start date

2011-11-29

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 INN of investigational material : ranirestat Therapeutic category code : 129 Other agents affecting peripheral nervous system Dosage and Administ

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

Measure	Time frame
Nerve conduction velocity, clinical symptoms and signs Last observation	—

Secondary

Measure	Time frame
Amplitude, F-wave minimum latency Last observation	—

Outcome results

None listed

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