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Completed

NCT Number: NCT00576277

Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV411 in 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.

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Key information

Conditions

Diabetic Neuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Adelaide, Adelaide, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AV411

Drug

Primary outcomes

  1. Safety

  2. Tolerability

  3. Pharmacokinetic profile

  4. Pharmacodynamic profile

Secondary outcomes

  1. Brief Pain Inventory

  2. Visual Analog Scale

  3. Clinical Global Impression of Change

  4. Use of analgesic or adjuvant medications for neuropathic pain

  5. Correlation between plasma concentrations of AV411 and pain intensity assessments

Sponsors and collaborators

Lead sponsor

Avigen

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Dec 19, 2007
Registry last updated
Dec 19, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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