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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00576277
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : December 19, 2007
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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.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathy Drug: AV411 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : September 2006
Actual Study Completion Date : November 2007

Primary Outcome Measures :
  1. Safety
  2. Tolerability
  3. Pharmacokinetic profile
  4. Pharmacodynamic profile

Secondary Outcome Measures :
  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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00576277

University of Adelaide
Adelaide, Australia
Peninsular Specialist Centre
Kipparing, Australia
Sponsors and Collaborators
Avigen Identifier: NCT00576277     History of Changes
Other Study ID Numbers: AV411-010
First Posted: December 19, 2007    Key Record Dates
Last Update Posted: December 19, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Diabetic Neuropathies
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases