None listed
Conditions
Brief summary
HIV associated painful sensory neuropathy (HIV-SN) is a common and disabling neurological complication of HIV infection, that may result from damage to sensory nerves from either HIV disease itself and/or as a side effect some of the medications used to treat the HIV infection. The damaged sensory nerves develop increased activity and transmit excessive pain signals, even when no pain stimuli are present. Pain in the feet is the most frequent symptom, as well as burning and painful soles and/or numbness usually occurring bilaterally in the extremities. There has been considerable research into the treatment of painful HIV-SN, but current therapies typically afford inadequate relief of symptoms and may have unpleasant side effects. Flupirtine is an orally available, centrally acting non-opioid analgesic that has been used in Germany for the treatment of acute pain, back pain and muscle stiffness since 1984. The purpose of this study is to investigate if the pain relieving drug flupirtine is a safe and effective treatment for painful HIV-SN when used together with opioid medication.
Interventions
There are six treatment groups in this study;
A. Placebo to be taken orally four times daily (QID)
B. Placebo to be taken orally QID
C. 25mg flupirtine to be taken orally (QID)
D. 50mg flupirtine to be taken orally QID
E. 75mg flupirtine to be taken orally QID
F. 100mg flupirtine to be taken orally QID
Patients will be randomised in a double blind fashion to receive each of the six treatment groups.
Patients will be asked to take one of the doses of the study drug for one week, followed by a
There are six treatment groups in this study; A. Placebo to be taken orally four times daily (QID) B. Placebo to be taken orally QID C. 25mg flupirtine to be taken orally (QID) D. 50mg flupirtine to be taken orally QID E. 75mg flupirtine to be taken orally QID F. 100mg flupirtine to be taken orally QID Patients will be randomised in a double blind fashion to receive each of the six treatment groups. Patients will be asked to take one of the doses of the study drug for one week, followed by a week where no study drug is taken. This will be followed by another week of study drug, and so on until each of the study drug doses is taken. Patients will be exposed to the study drug for a total of 6 weeks over a 13 week period.
Sponsors
CNSBio Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1.Between 18 and 80 years of age and able to speak and understand English 2.Documented evidence of HIV infection. 3.Documented baseline diagnosis of painful HIV-Sensory Neuropathy (HIV-SN) resulting from HIV disease and/or antiretroviral drug exposure for at least 3 months prior to the beginning of the study . 4.The pain is classified as neuropathic during screening according to the neuropathic pain questionnaire. 5. Average score (as assessed by a modified brief pain inventory) for HIV-SN associated pain during screening of > 5. 6.Must be on a stable pain medication regimen for at least 21 days prior to Day -1 of the study and willing to maintain medications at same stable dose(s) and schedule throughout the study. 7.Must be taking opioids for 3 months prior to the trial and must be willing to maintain opioid use at same stable dose(s) and schedule throughout the study (excluding the use of break-through pain medication). 8.Female subjects with child-bearing potential must have a negative urine beta human chorionic gonadotropin (hCG) pregnancy test, to be performed within 7 days of study enrolment, and each week before study drug is to be ingested (total of 7 times) 9.All subjects must 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 study drug exposure. 10.Be willing and able to comply with protocol requirements for the duration of study participation. (Such requirements include, but are not limited to: completing a daily pain diary, attending all study visits which includes refraining from extensive travel during study participation.) 11.Subjects must sign an informed consent form for this study approved by the Investigator’s Institutional ethics committee.
Exclusion criteria
1 Are Pregnant or breast feeding 2.Suffer from significant lactose intolerance that in the opinion of the investigator would interfere either with the ability to complete the study or the evaluation of the investigative drugs safety and efficacy 3.Are taking warfarin 4.Have myasthenia gravis or epilepsy 5.Have significant uncompensated abnormal liver or kidney function (liver and renal function tests three times (or greater) than the upper limit for the normal reference ranges). 6.Have an active substance abuse or psychiatric problem that in the opinion of the investigator is deemed likely to interfere with the study. 7.Have started or stopped treatment with one or more of the known neurotoxic antiretroviral agents during the eight weeks prior to Day -1 os the study. 8.Have evidence of another contributing cause for peripheral neuropathy, e.g. current uncontrolled diabetes mellitus, hereditary neuropathy, or treatment (within 90 days prior to Screening Visit) with any drug that may have contributed to the sensory neuropathy . 9.Have hypertension, unless adequately controlled by medication. 10.Have significant pain of an etiology other than painful HIV-SN which the investigators deem likely to interfere with judging HIV-SN related pain. 11.Have had any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator), nerve block or anesthetic procedure to the presumed site of nerve damage for the treatment of neuropathic pain within two weeks of the study. 12.Have significant medical abnormalities or conditions that in the opinion of the investigator would interfere either with the ability to complete the study or the evaluation of the investigative drugs safety and efficacy. 13.Have a recent history of a significant medical-surgical intervention that in the judgment of the Investigator would interfere either with the ability to complete the study or the evaluation of the investigative drugs safety and efficacy. 14.Are to be commenced on anticonvulsants or antidepressants during the course of the trial, or are likely to require the doses of these drugs to be altered during the trial.
Outcome results
None listed