Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000403538
Ethics application status
Approved
Date submitted
12/09/2006
Date registered
13/09/2006
Date last updated
13/09/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of AV411 in neuropathic pain
Scientific 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
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic neuropathy or Complex regional pain syndrome 1369 0
Condition category
Condition code
Metabolic and Endocrine 1462 1462 0 0
Diabetes
Neurological 1463 1463 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral AV411 (20, 30, or 40 mg) two or three times daily for 24 days
Intervention code [1] 1348 0
Treatment: Drugs
Comparator / control treatment
Oral two or three times daily placebo for 24 days
Control group
Placebo

Outcomes
Primary outcome [1] 2023 0
Safety and tolerability
Timepoint [1] 2023 0
At screening and followed-up daily
Primary outcome [2] 2024 0
Pharmacokinetic profile
Timepoint [2] 2024 0
On Study Days 2, 8, 21, and 24
Primary outcome [3] 2025 0
Pharmacodynamic profile
Timepoint [3] 2025 0
On Study Days 2, 8, 21, and 24
Secondary outcome [1] 3490 0
Brief Pain Inventory
Timepoint [1] 3490 0
On Study Days 1, 2, 8, 21, and 24
Secondary outcome [2] 3491 0
Visual Analog Scale
Timepoint [2] 3491 0
Daily
Secondary outcome [3] 3492 0
Clinical Global Impression of Change (patient)
Timepoint [3] 3492 0
On Study Days 1, 2, 8, 21, and 24
Secondary outcome [4] 3493 0
Use of analgesic or adjuvant medications for chronic neuropathic pain
Timepoint [4] 3493 0
Daily
Secondary outcome [5] 3494 0
Correlation between plasma concentrations of AV411 and pain intensity
Timepoint [5] 3494 0
Assessments on Study Days 2, 8, 21, and 24

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 <100,000 mm3 or a history of thrombocytopenia.-Known or suspected chronic liver disease.-GFR <= 90 mL/min/1.73m2 (Cockcroft-Gualt).-Female subjects who are pregnant or nursing mothers.-Received an investigational drug in the past 90 days.-Unable to swallow large capsules.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Fixed stratified system based on previous treatment
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subject and Investigator are blinded
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1600 0
Commercial sector/Industry
Name [1] 1600 0
Avigen, Inc.
Country [1] 1600 0
Primary sponsor type
Commercial sector/Industry
Name
Avigen, Inc.
Address
Country
United States of America
Secondary sponsor category [1] 1405 0
None
Name [1] 1405 0
None
Address [1] 1405 0
Country [1] 1405 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27955 0
Address 27955 0
Country 27955 0
Phone 27955 0
Fax 27955 0
Email 27955 0
Contact person for public queries
Name 10537 0
Paul Rolan, MBBS, MD, FRACP, FFPM, DCPSA
Address 10537 0
Department of Clinical and Experimental Pharmacology
Medical School-5th Level
University of Adelaide
Adelaide SA 5005
Country 10537 0
Australia
Phone 10537 0
61-8-8303-4102
Fax 10537 0
61-8-8224-0685
Email 10537 0
paul.rolan@adelaide.edu.au
Contact person for scientific queries
Name 1465 0
Paul Rolan, MBBS, MD, FRACP, FFPM, DCPSA
Address 1465 0
Department of Clinical and Experimental Pharmacology
Medical School-5th Level
University of Adelaide
Adelaide SA 5005
Country 1465 0
Australia
Phone 1465 0
61-8-8303-4102
Fax 1465 0
61-8-8224-0685
Email 1465 0
paul.rolan@adelaide.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.