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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00576277




Registration number
NCT00576277
Ethics application status
Date submitted
17/12/2007
Date registered
19/12/2007
Date last updated
19/12/2007

Titles & IDs
Public title
Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy 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
Secondary ID [1] 0 0
AV411-010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Neuropathy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AV411

Treatment: Drugs: AV411
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety
Timepoint [1] 0 0
Primary outcome [2] 0 0
Tolerability
Timepoint [2] 0 0
Primary outcome [3] 0 0
Pharmacokinetic profile
Timepoint [3] 0 0
Primary outcome [4] 0 0
Pharmacodynamic profile
Timepoint [4] 0 0
Secondary outcome [1] 0 0
Brief Pain Inventory
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Visual Analog Scale
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Clinical Global Impression of Change
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Use of analgesic or adjuvant medications for neuropathic pain
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Correlation between plasma concentrations of AV411 and pain intensity assessments
Timepoint [5] 0 0

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 <100,000mm3 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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2007
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
University of Adelaide - Adelaide
Recruitment hospital [2] 0 0
Peninsular Specialist Centre - Kipparing
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Kipparing

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Avigen
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00576277
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00576277