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A multicenter, randomized, double blind, placebo controlled multiple dose study of the efficacy and safety of AS-3201 in patients with DSP (diabetic sensorimotor polyneuropathy). [Phase II]

A multicenter, randomized, double blind, placebo controlled multiple dose study of the efficacy and safety of AS-3201 in patients with DSP (diabetic sensorimotor polyneuropathy). [Phase II]

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220465
Enrollment
Unknown
Registered
2007-11-08
Start date
2007-11-08
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 sensorimotor polyneuropathy

Interventions

investigational material(s) Generic name etc : AS-3201 (ranirestat) INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational

Sponsors

Dainippon Sumitomo Pharma Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with DSP who satisfy the following inclusion criteria - Patients who have DSP symptoms, signs and abnormal nerve conduction on the basis of pre-defined criteria - Patients aged 20 to 75 - Outpatients etc. - 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Efficacy: nerve conduction velocity, etc—

Outcome results

None listed

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