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

December 17, 2007 updated by: Avigen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
        • University of Adelaide
      • Kipparing, Australia
        • Peninsular Specialist Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety
Pharmacodynamic profile
Tolerability
Pharmacokinetic profile

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avigen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

December 17, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 19, 2007

Study Record Updates

Last Update Posted (Estimate)

December 19, 2007

Last Update Submitted That Met QC Criteria

December 17, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AV411-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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