Study Evaluating EAA-090 in Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of 3 Fixed Doses of EAA-090 in Adult Outpatients With Neuropathic Pain Associated With Diabetic Neuropathy

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00073034

Enrollment

Unknown

Registered

2003-11-18

Start date

2004-01-31

Completion date

2004-12-31

Last updated

2013-02-21

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

Conditions

Diabetes Mellitus, Diabetic Neuropathy, Painful

Keywords

Neuropathic Pain, Diabetic Neuropathy

Brief summary

EAA-090 is being developed for the treatment of neuropathic pain associated with diabetic neuropathy. It is a selective antagonist that binds competitively to the glutamate site of the N-methyl-D-aspartate (NMDA) receptor. This study will assess the safety and efficacy of 3 fixed oral doses of EAA-090 compared with placebo in subjects with neuropathic pain associated with diabetic neuropathy.

Interventions

DRUGEAA-090

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Women of childbearing potential must have a negative serum pregnancy test result at screening * Diabetes mellitus (type I or II) that is controlled by oral or parenteral hypoglycemic agents or diet * Diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy

Exclusion criteria

* Pregnancy, lactation, or plans to become pregnant during the study * Depo-Provera or oral contraceptives that have been taken for less than 1 month before study day 1 if not using another medically accepted form of birth control * History of multiple drug allergies that may put the subject at greater risk during study participation in the opinion of the investigator

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026