None listed
Conditions
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.
Interventions
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 su
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.
Sponsors
CNSBio Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed