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

This study has been completed.
Sponsor:
Information provided by:
Avigen
ClinicalTrials.gov Identifier:
NCT00576277
First received: December 17, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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 Intervention Phase
Diabetic Neuropathy
Drug: AV411
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Avigen:

Primary Outcome Measures:
  • Safety
  • Tolerability
  • Pharmacokinetic profile
  • Pharmacodynamic profile

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

Estimated Enrollment: 36
Study Start Date: September 2006
Study Completion Date: November 2007
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576277

Locations
Australia
University of Adelaide
Adelaide, Australia
Peninsular Specialist Centre
Kipparing, Australia
Sponsors and Collaborators
Avigen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00576277     History of Changes
Other Study ID Numbers: AV411-010
Study First Received: December 17, 2007
Last Updated: December 17, 2007
Health Authority: Australia: Human Research Ethics Committee

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

ClinicalTrials.gov processed this record on September 16, 2014