RecruitingPhase 2ACTRN12606000403538

Investigation of AV411 in neuropathic pain

A prospective, double-blind, randomized, placebo-controlled trial of AV411 to assess its safety tolerability, pharmacokinetics and preliminary efficacy in the treatment of neuropathic pain


Sponsor

Avigen, Inc.

Enrollment

36 participants

Start Date

Sep 15, 2006

Study Type

Interventional

Conditions


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AV411 (ibudilast) to see if it can reduce pain in people with nerve pain (neuropathic pain). Nerve pain is a burning, shooting, or electric-shock-like pain caused by damage to the nerves, and it can be very difficult to treat. This study focuses on people with either diabetic neuropathy (nerve damage from diabetes) or complex regional pain syndrome (CRPS). AV411 works differently from most pain medications — it targets brain immune cells rather than nerve signals — which may make it effective for conditions where standard treatments do not work well. You may be eligible if: - You are between 18 and 70 years old - You have been diagnosed with diabetic neuropathy or complex regional pain syndrome for at least 6 months - Your pain score is 4 or higher on a 10-point scale - You have been on stable pain medications for at least 8 weeks - You are willing to use barrier contraception during the study - Female participants of childbearing potential must have a negative pregnancy test You may NOT be eligible if: - You have untreated mental illness, drug addiction, or alcohol abuse - You have donated blood in the past 90 days - You have a low platelet count or a history of bleeding problems - You have chronic liver disease - You have reduced kidney function (GFR 90 mL/min/1.73m² or less) - You are pregnant or breastfeeding - You have taken another investigational drug in the past 90 days Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Oral AV411 (20, 30, or 40 mg) two or three times daily for 24 days

Oral AV411 (20, 30, or 40 mg) two or three times daily for 24 days


Locations(1)

Australia

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ACTRN12606000403538