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

Primary Purpose

Diabetic Neuropathy

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
AV411
Sponsored by
Avigen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Adelaide
  • Peninsular Specialist Centre

Outcomes

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

Full Information

First Posted
December 17, 2007
Last Updated
December 17, 2007
Sponsor
Avigen
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1. Study Identification

Unique Protocol Identification Number
NCT00576277
Brief Title
Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV411 in Neuropathic Pain
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 Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Avigen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
AV411
Primary Outcome Measure Information:
Title
Safety
Title
Tolerability
Title
Pharmacokinetic profile
Title
Pharmacodynamic profile
Secondary Outcome Measure Information:
Title
Brief Pain Inventory
Title
Visual Analog Scale
Title
Clinical Global Impression of Change
Title
Use of analgesic or adjuvant medications for neuropathic pain
Title
Correlation between plasma concentrations of AV411 and pain intensity assessments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Adelaide
City
Adelaide
Country
Australia
Facility Name
Peninsular Specialist Centre
City
Kipparing
Country
Australia

12. IPD Sharing Statement

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

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