A placebo controlled multiple dose study of flupirtine in the treatment of painful Human Immunodeficiency Virus (HIV) -associated neuropathy.

Phase 2

Completed

• Conditions: painful HIV-associated neuropathy; Neurological - Other neurological disorders; Infection - Acquired immune deficiency syndrome (AIDS / HIV)

• Registration Number: ACTRN12608000315314
• Lead Sponsor: CNSBio Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of flupirtine for the treatment of pain due to HIV-Sensory Neuropathy (SN), in patients who have pain inadequately controlled by opioids. <br><br>Efficacy will be assessed using patient responses to the Brief Pain Inventory and pain rating on a visual analogue safety.[Study participants are assessed weekly for 13 weeks.];To assess the safety of flupirtine for the treatment of pain due to HIV-SN, in patients who have pain inadequately controlled by opioids.<br><br>Safety will be assessed using patient rating of reported side effects and adverse events, and from the results of blood, liver and renal function tests.[Study participants are assessed weekly for 13 weeks.]

Secondary Outcome Measures

Name	Time	Method
To describe doses of flupirtine and opioids which, when used concomitantly increase quality of life (QoL).<br><br>QoL will be assessed using patient responses to a health and activity survey.[Study participants are assessed weekly for 13 weeks.];To describe doses of flupirtine and opioids which, when used concomitantly increase pain relief.<br><br>Pain relief will be assessed using patient responses to the Brief Pain Inventory and pain rating on a visual analogue safety.[Study participants are assessed weekly for 13 weeks.]