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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
Request Number:
082893
ACTR Number:
ACTRN12608000319370
Trial Status:
Registered
Date Submitted:
11/06/2008
Date Registered:
10/07/2008
Page 1
Public title:
A one-year, open label, extension study of flupirtine for the treatment of painful Human Immunodeficiency Virus (HIV)-sensory neuropathy (SN) in patients who have pain inadequately controlled by opioids
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ANZCTR registration title:
A one-year, open label, extension study of flupirtine for the treatment of painful HIV-sensory neuropathy in patients who have pain inadequately controlled by opioids
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Secondary ID:
UTN:
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Trial acronym:
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Page 2
Health condition(s) or problem(s) studied:
painful HIV - sensory neuropathy
Condition category:
Condition code:
Anaesthesiology
Pain management
Infection
Acquired immune deficiency syndrome (AIDS / HIV)
Page 3
Description of intervention(s) / exposure:
This is a one-year extension study to investigate the long-term safety, tolerability and efficacy of open label flupirtine for the treatment of painful HIV-SN in patients who have pain inadequately controlled by opioids.
The study will consist of a Dose Optimisation Stage (Stage 1) and a second Dose Maintenance Stage (Stage 2).
The Dose Optimisation Stage of the study consists of a variable number of 2-week study periods during which the dose of flupirtine will be optimised for each study subject individually in response to feedback regarding pain, side effects and Quality of Life (QoL) during study visits. Minor adjustments to opioid dose may also occur if pain control is maintained and side effects experienced by the study subjects suggest opioid excess.
Study subjects will begin the Dose Optimisation Stage with the introduction of 200-300mg/day flupirtine (2 - 3 capsules) to be taken orally along with their regular opioid medication. The dose of flupirtine and opioid medication may be adjusted fortnightly by the Principle Investigator using patient feedback, pain and QoL scores.
Dose optimisation will continue fortnightly until:
1.the study subject experiences effective pain relief at a flupirtine dose that does not produce side effects that in the opinion of the patient are unacceptable
2.the study subject has reached the maximum flupirtine dose of 600mg.
3.the patient does not wish to continue
4.it is the opinion of the Principle Investigator that dose optimisation should not continue.
it is anticipated that Dose Optimisation stage of the trial will last approximately 2 - 3 months. At the conclusion of the Dose Optimisation Stage the Principle Investigator shall, in consultation with the study subject and using pain scores, reported side effects and QoL responses as a guide, choose the best dose of flupirtine (to be taken in combination with opioids ) for the study subject. The study subject may remain on this dose combination during the Dose Maintenance Phase and the remainder of the extension study.
During the Dose Maintenance Stage of the study, subjects will be required to attend the study site monthly for assessment and dispensing of flupirtine. Drug doses may be re-optimised by the Principle Investigator (according to study subject feedback as per the Dose Optimisation Stage) during the Dose Maintenance Stage. It is anticipated that the Dose Maintenance Stage of the trial will last 9 - 10 months.
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Intervention code:
Treatment: drugs
Comparator / control treatment:
none
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Control group:
Uncontrolled
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Page 4
Primary outcome:
To investigate the long-term safety of flupirtine for the treatment of painful HIV-SN in patients who have pain inadequately controlled by opioids. Safety will be assessed using study subject reports of adverse events and pathology results of liver, renal and blood function tests.
Timepoint:
Study participants are assessed fortnightly during Stage 1 and monthly during stage 2 of the trial.
Secondary outcome 1:
To investigate the long-term tolerability of flupirtine for the treatment of painful HIV-SN in patients who have pain inadequately controlled by opioids. Tolerability will be assessed using study subjects reports of side effects and adverse events.
Timepoint:
Study participants are assessed fortnightly during Stage 1 and monthly during stage 2 of the trial.
Secondary outcome 2:
To investigate the efficacy of flupirtine for the treatment of painful HIV-SN in patients who have pain inadequately controlled by opioids. Efficacy will be assessed using study subject feedback related to pain questionairres.
Timepoint:
Study participants are assessed fortnightly during Stage 1 and monthly during stage 2 of the trial.
Secondary outcome 3:
To describe doses of flupirtine and opioids which, when used concomitantly, may increase the pain relief and QoL of patients who have pain due to painful HIV-SN which is inadequately controlled by opioids alone.
Timepoint:
Study participants are assessed fortnightly during Stage 1 and monthly during stage 2 of the trial.
Page 5
Key inclusion criteria:
In order to be eligible for this study, subjects must:
1.give informed consent
2.have completed the primary study identified by the protocol number CNSBio 01/07 . Study subjects who did not complete CNSBio 01/7 may be enrolled in this study with the approval of the Principle Investigator and the Sponsor.
3.be willing to maintain opioid use throughout the study
4.begin the study within 1 month of completing the CNSBio 01/07 (primary study) termination, 1 month or 3 month follow-up visit.
5.have a negative urine ßHcG pregnancy test, to be performed within 7 days of study enrolment and monthly during the extension study .
6.be willing to use effective methods of birth control and/or refrain from participating in a conception process during the study and for 30 days following IP exposure.
7.be willing and able to comply with protocol requirements for the duration of study participation. Such requirements include, but are not limited to attending all study visits for assessments and study drug dispensing.
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Minimum Age:
18
Years
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Maximum Age:
80
Years
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Gender:
Both males and females
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Healthy volunteers?
No
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Key exclusion criteria:
In order to be eligible for this study, subjects must not: 1.be pregnant or breast feeding. 2.be taking warfarin. 3.have myasthenia gravis or epilepsy . 4.have significant uncompensated abnormal liver or kidney function. 5.have hypertension, unless adequately controlled by medication.
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Page 6
Study type:
Interventional
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Purpose of the study:
Treatment
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Allocation to intervention:
Nonrandomised trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures):
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
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Masking / blinding:
Open (masking not used)
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Assignment:
Single group
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Other design features (specify):
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Type of endpoint(s):
Safety/efficacy
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Page 7
Phase
Not Applicable
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Anticipated or actual date of first participant enrolement:
1/07/2008
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Target sample size:
12
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Recruitment status:
Closed: follow-up complete
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Page 8
Funding source:
Commercial sector/Industry
Name:
CNSBio Pty Ltd
Address:
Suite 1, 651 Victoria St Abbotsford, 3067
Country:
Australia
Primary sponsor:
Commercial sector/Industry
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Reason:
Name:
CNSBio Pty Ltd
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Address:
Suite 1, 651 Victoria St Abbotsford, 3067 Victoria
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Country:
Australia
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Secondary sponsor:
None
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Address:
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Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
Yes
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Reason:
Ethics Committee name 1:
The Alfred Hospital Ethics Committee
Address:
63-65 Commercial Road Melbourne 3004 Victoria
Country:
Australia
Date of approval:
1/05/2008
HREC Number:
97/08
Ethics Committee name 2:
St Vincents Hospital Human Research Ethics Committee
Address:
St Vincents Hospital
Country:
Australia
Date of approval:
14/05/2008
HREC Number:
08/81
Countries of recruitment:
Australia
Brief summary:
Painful HIV-SN is a neurological complication of HIV infection that can result from either the HIV disease process itself and/or from the use of some of the anti-retroviral medications that are used to treat HIV. There has been considerable research into the treatment of painful HIV-SN neuropathy. However, treatment with currently available pain killing medications rarely renders the patient pain free and the use of medications may be limited by side effects.
This current research project is only being offered to the participants who have taken part in the previous research project entitled “A placebo controlled multiple dose research project of Flupirtine for the treatment of painful HIV-SN”.
The previous study has the protocol number CNSBio 01/07. “CNSBio 01/07” is investigating the short-term (one week) effectiveness and safety of the pain killing medication Flupirtine when taken in combination with opioids for the treatment of painful HIV-SN. CNSBio 01/07 is not yet completed and the results of this clinical trial are not yet available.
The purpose of this research project is to investigate further if the drug Flupirtine is a safe and effective treatment for HIV-SN when taken in combination with opioids for longer than a week (up to one year).
Flupirtine is an experimental treatment. This means that currently the drug is not an approved treatment for painful HIV-SN in the United States by the Food and Drug Administration (FDA) or in Australia by the Therapeutic Goods Administration (TGA). It is however approved for the treatment of back pain, muscle stiffness and pain associated with surgery and arthritis in Germany, Russia, Portugal, China and Brazil. CNSBio Pty Ltd is sponsoring the current research project with the aim of developing Flupirtine for the treatment of painful HIV-SN in Australia and America if flupirtine proves to be safe and effective in this context.
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Trial website:
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Presentations / publication list:
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Page 10
Contact person for public queries
Name:
Dr. Claudia Gregorio-King
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Address:
Suite 1, 651 Victoria St
Abbotsford, 3067
Victoria
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Country:
Australia
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Tel:
03-8663 7301
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Fax:
03-9421 0444
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Email:
claudia.gregorio-king@cnsbio.com
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Contact person for scientific queries
Name:
Dr. Catherine Cherry
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Address:
Infectious Diseases
Level 2
Burnet Institute
Commercial Road
Melbourne VIC 3004
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Country:
Australia
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Tel:
03-9282-2278
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Fax:
03-95302836
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Email:
kcherry@burnet.edu.au
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Contact person responsible for updating information
Name:
Dr. Claudia Gregorio-King
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Address:
Suite 1, 651 Victoria St
Abbotsford, 3067
Victoria
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Country:
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Tel:
03-8663 7301
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Fax:
03-9421 0044
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Email:
claudia.gregorio-king@cnsbio.com
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