Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV411 in Neuropathic Pain - Full Text View

Sponsored by:	Avigen
Information provided by:	Avigen
ClinicalTrials.gov Identifier:	NCT00576277

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 I Phase II

MedlinePlus related topics: Diabetic Nerve Problems

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
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

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

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

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

Study placed in the following topic categories:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus

Endocrine System Diseases
Pain
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009