Clinical trial NCT01135251 (phase 2, status: completed)
Conditions: neuropathy, aids
ICD codes: G58.0, G61.1, A52.15, G60.3, G61.82, H46.2, H46.3
Drugs: dimiracetam, sugar pill
SMILES: O=C1CN2C(CCC2=O)N1, OC[C@H]1O[C@@](CO)(O[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@@H]1O
Eligibility criteria:

        Inclusion Criteria:

          -  male and female aged 18-65 years;

          -  females of child-bearing potential only if using a medically accepted method of
             contraception with a second method of birth control, medically prescribed intrauterine
             device (IUD), or double barrier method (condom in combination with spermicidal) prior
             to screening and agreeing to continue its use during the whole duration of the study;

          -  HIV-positive patients treated with ARTs;

          -  CD4+ cell count > 200/L at the screening;

          -  patients affected by neuropathic pain caused by ARTs;

          -  naïve neuropathic patients or non-responders (residual pain ≥40 mm on the VAS) to
             standard neuropathy treatments. Drugs for neuropathic pain (NP) must be stopped at
             screening visit;

          -  pain intensity ≥40 mm on the VAS at screening;

          -  pain intensity ≥40 mm on the VAS as the mean of the values collected on the last 4
             days prior to the start of treatment (baseline VAS);

          -  life expectancy of at least 6 months;

          -  ability to comprehend the full nature and purpose of the study, including possible
             risks and side effects;

          -  ability to co-operate with the Investigator or designee and to comply with the
             requirements of the entire study;

          -  signed written informed consent prior to inclusion in the study

        Exclusion Criteria:

          -  pregnant or lactating females;

          -  patients with neuropathic pain due to other factors than the ARTs; any clinically
             significant underlying disease, according to the Investigator's clinical judgement;

          -  history of psychosis (e.g. schizophrenia or psychotic depression) or major depression
             ;

          -  any current axis I diagnosis including dementia, depression, psychosis, anxiety
             disorders, mental retardation;

          -  participation in the evaluation of any investigational drug within 3 months prior to
             screening (6 months in the neuropathic pain). Use of an investigational drug other
             than dimiracetam during the study is not permitted;

          -  treatment with neurostimulating devices such as spinal cord stimulation (SCS),
             acupuncture, homeopathic remedies for pain or any kind of surgical treatment or
             blockade for the pain in the 4 weeks prior to screening;

          -  treatment with any drug for neuropathic pain (NP) after the screening visit;
             requirement of more than 2 transfusions / month to achieve haemoglobin level > 8 g/dL;

          -  history of alcohol abuse (defined according to USDA dietary guidelines) or drug abuse
             during the last 3 months prior to screening;

          -  history of allergic response to neuropathic treatments or history of anaphylaxis or
             allergic reactions to drugs in general;

          -  any abnormality that the Investigator deems to be clinically relevant, either on
             medical history, physical examination, ECG or in diagnostic laboratory test;

          -  subjects likely to be non-compliant or uncooperative during the study according to the
             Investigator or designee's judgement