Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV411 in Neuropathic Pain

Phase 1

Completed

• Conditions: Diabetic Neuropathy

• Registration Number: NCT00576277
• Lead Sponsor: Avigen

Brief Summary

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of AV411 after single and multiple doses in patients with chronic neuropathic pain due to diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Status Verified: 2007-04
• Study Completion: 2007-11
• Study First Submitted: 2007-12-17
• Study First Submitted QC: 2007-12-17
• Last Update Submitted: 2007-12-17
• Study First Posted: 2007-12-19
• Last Update Posted: 2007-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Diagnosis of diabetic neuropathy or complex regional pain syndrome of at least 6 months duration
• VAS score of 4 cm or higher at Screening
• No clinical abnormality in laboratory and urine analyses
• Electrocardiogram within normal limits at Screening
• Negative pregnancy test on Study Day 1 for female subjects of childbearing potential
• On stable doses of medications, analgesic or others for at least 8 weeks prior to study enrollment
• Willing to use barrier contraceptive during the period of the study

Exclusion Criteria

• Known hypersensitivity to AV411 or its components
• Conditions which might affect drug absorption, metabolism or excretion
• Untreated mental illness, current drug addiction or abuse or alcoholism
• Donated blood in the past 90 days or have poor peripheral venous access
• Platelets <100,000mm3 or a history of thrombocytopenia
• Known or suspected chronic liver disease
• GFR <=90mL/min/1.73m2 (Cockcroft-Gault)
• Female subjects who are pregnant or nursing mothers
• Received an investigational drug in the past 90 days
• Unable to swallow large capsules

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety
Tolerability
Pharmacokinetic profile
Pharmacodynamic profile

Secondary Outcome Measures

Name	Time	Method
Brief Pain Inventory
Visual Analog Scale
Clinical Global Impression of Change
Use of analgesic or adjuvant medications for neuropathic pain
Correlation between plasma concentrations of AV411 and pain intensity assessments

Trial Locations

Locations (2)

University of Adelaide; 🇦🇺 Adelaide, Australia

Peninsular Specialist Centre; 🇦🇺 Kipparing, Australia