Investigation of AV411 in neuropathic pai

Phase 1

Recruiting

• Conditions: Diabetic neuropathy or Complex regional pain syndrome; Metabolic and Endocrine - Diabetes; Neurological - Pain management

• Registration Number: ACTRN12606000403538
• Lead Sponsor: Avigen, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• 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 <100,000 mm3 or a history of thrombocytopenia.-Known or suspected chronic liver disease.-GFR <= 90 mL/min/1.73m2 (Cockcroft-Gualt).-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: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability [At screening and followed-up daily];Pharmacokinetic profile [On Study Days 2, 8, 21, and 24];Pharmacodynamic profile [On Study Days 2, 8, 21, and 24]

Secondary Outcome Measures

Name	Time	Method
Brief Pain Inventory [On Study Days 1, 2, 8, 21, and 24];Visual Analog Scale[Daily];Clinical Global Impression of Change (patient)[On Study Days 1, 2, 8, 21, and 24];Use of analgesic or adjuvant medications for chronic neuropathic pain[Daily];Correlation between plasma concentrations of AV411 and pain intensity[ Assessments on Study Days 2, 8, 21, and 24]