Diabetic NeuropathyPhase 1/2NCT00576277
Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV411 in Neuropathic Pain
A Phase 1/2 study testing AV411 in people with Diabetic Neuropathy, run by Avigen at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Neuropathy
- What is being tested?
- AV411
- How many people
- 36 participants
- Where
- 2 sitesAustralia
- Study dates
- Sep 2006to Nov 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
University of Adelaide
Adelaide
Peninsular Specialist Centre
Kipparing
About this 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
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.
- Conditions
- Diabetic Neuropathy
- Being tested
- AV411
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV411Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Tolerability
Pharmacokinetic profile
Pharmacodynamic profile
Secondary outcomes (5)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startSep 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avigen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576277
- Sponsor's protocol ID
- AV411-010
- Status last verified
- Apr 2007
- First submitted
- 17 Dec 2007
- Last updated
- 19 Dec 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00576277
- Acronym / sponsor ID
- AV411-010
- Conditions
- Diabetic Neuropathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- AvigenIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- Nov 2007 (actual)
- First posted
- 19 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AV411 | Drug | – |
Primary outcome
Safety
Tolerability
Pharmacokinetic profile
Pharmacodynamic profile
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AV411 in people with Diabetic Neuropathy, run by Avigen at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2007.