Dimiracetam in Painful Neuropathies Affecting AIDS Patients (DIPANAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01444690
Recruitment Status : Unknown
Verified September 2011 by Neurotune AG.
Recruitment status was:  Not yet recruiting
First Posted : October 3, 2011
Last Update Posted : October 3, 2011
Information provided by (Responsible Party):
Neurotune AG

September 29, 2011
October 3, 2011
October 3, 2011
January 2012
January 2013   (Final data collection date for primary outcome measure)
  • Pain intensity measured on 100 mm VAS [ Time Frame: 71 days ]
    Change from baseline in pain intensity as measured on VAS
  • Pain intensity as measured with Total Symptom Score (TSS) [ Time Frame: 71 days ]
    Change from baseline as measured with TSS
Same as current
No Changes Posted
  • Adverse events [ Time Frame: 78 days ]
    Comparison of AE frequency between treatment groups
  • Number needed to treat [ Time Frame: 71 days ]
    NNT needed to obtain a >60% pain relief from the initial score recorded on the VAS and TSS at study entry
  • CD4+ cell count [ Time Frame: 78 days ]
    comparison of CD4+ cell count vs. baseline within and between treatment groups
  • HIV viral load [ Time Frame: 78 days ]
    comparison of HIV viral load vs. screening within and between treatment groups
Same as current
Not Provided
Not Provided
Dimiracetam in Painful Neuropathies Affecting AIDS Patients
Dimiracetam in Painful Neuropathies Affecting AIDS Patients. A Double-blind, Placebo-controlled, Parallel-group, Randomised, Multi-centre Study
The purpose of this study is to assess the efficacy and tolerability of orally administered dimiracetam for 10 weeks to AIDS patients under treatment with antiretroviral agents presenting a disease and /or treatment related neuropathic pain.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Acquired Immunodeficiency Syndrome
  • Drug: Dimiracetam
    Capsules for oral administration twice daily
  • Drug: Dimiracetam 25 mg
    Inactive dose level in capsules administered orally twice daily
  • Experimental: Active
    Dimiracetam 400 mg capsules
    Intervention: Drug: Dimiracetam
  • Placebo Comparator: Pseudo-placebo
    Dimiracetam 25 mg capsules
    Intervention: Drug: Dimiracetam 25 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
January 2013
January 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • male and female patients aged 18-75 years inclusive;
  • females of child-bearing potential only if agreeing prior to screening to use a medically accepted method of contraception, i.e., oral or injectable hormonal contraceptive with a second method of birth control, medically prescribed intrauterine device (IUD), or double barrier method (condom in combination with spermicidal). Females, who are not currently sexually active, only if agreeing and consenting to use one of the above-mentioned methods in case they become sexually active while participating in the study;
  • females of not child-bearing potential only if permanently sterilised or if in post-menopausal status, only if they have been in this status for at least 2 years; females of not child-bearing potential are exempted from the requirement for use of contraception;
  • HIV-positive patients treated with ARTs;
  • CD4+ cell count > 200/μL at the screening;
  • patients affected by current neuropathic pain likely to be ART treatment related. The diagnosis shall be made by a physician and based on history, clinical and/or laboratory findings in accordance with the taxonomy of the diagnostic criteria documented in the International Association for the Study of Pain (IASP) Classification of Chronic Pain;
  • 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

Exclusion Criteria:

  • pregnant or lactating females;
  • presence of active AIDS-defining opportunistic infections (with the exception of tuberculosis) or malignant neoplasia requiring treatment at study entry or Kaposi's sarcoma or another malignant neoplasia likely to require chemotherapy;
  • any clinically significant underlying disease, according to the Investigator's clinical judgment;
  • history of psychosis (e.g. schizophrenia or psychotic depression) or major depression (requiring treatment);
  • any current DSM-IV 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 if for treatment of neuropathic pain)
  • 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 (no more than 4 drinks in a day and 14 drinks in a week for men or 3 drinks per day and 7 drinks in a week for women as defined according to both NIAAA and USDA dietary guidelines) or drug abuse during the last 3 mo prior to screening;
  • Less than 1 VAS assessment per day for each of the last 4 days.
  • 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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Neurotune AG
Neurotune AG
Not Provided
Study Director: Rugerro Fariello, MD Neurotune AG
Neurotune AG
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP