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

Diabetic Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576277
• Other study ID #: AV411-010
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 17, 2007
• Last updated: December 17, 2007
• Start date: September 2006
• Est. completion date: November 2007

Study information

• Verified date: April 2007
• Source: Avigen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Neuropathy
• Neuralgia

Intervention

Drug:
• AV411

Locations

Country	Name	City	State
Australia	University of Adelaide	Adelaide
Australia	Peninsular Specialist Centre	Kipparing

Sponsors (1)

Lead Sponsor	Collaborator
Avigen

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety
Primary	Tolerability
Primary	Pharmacokinetic profile
Primary	Pharmacodynamic profile
Secondary	Brief Pain Inventory
Secondary	Visual Analog Scale
Secondary	Clinical Global Impression of Change
Secondary	Use of analgesic or adjuvant medications for neuropathic pain
Secondary	Correlation between plasma concentrations of AV411 and pain intensity assessments