Dimiracetam in Painful Neuropathies Affecting AIDS Patients (DIPANAP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Neurotune AG.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Neurotune AG
ClinicalTrials.gov Identifier:
NCT01444690
First received: September 29, 2011
Last updated: September 30, 2011
Last verified: September 2011

September 29, 2011
September 30, 2011
January 2012
January 2013   (final data collection date for primary outcome measure)
  • Pain intensity measured on 100 mm VAS [ Time Frame: 71 days ] [ Designated as safety issue: No ]
    Change from baseline in pain intensity as measured on VAS
  • Pain intensity as measured with Total Symptom Score (TSS) [ Time Frame: 71 days ] [ Designated as safety issue: No ]
    Change from baseline as measured with TSS
Same as current
Complete list of historical versions of study NCT01444690 on ClinicalTrials.gov Archive Site
  • Adverse events [ Time Frame: 78 days ] [ Designated as safety issue: Yes ]
    Comparison of AE frequency between treatment groups
  • Number needed to treat [ Time Frame: 71 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    comparison of CD4+ cell count vs. baseline within and between treatment groups
  • HIV viral load [ Time Frame: 78 days ] [ Designated as safety issue: Yes ]
    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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
244
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
Both
18 Years to 75 Years
No
Contact: Rugerro Fariello, MD +41-91-6056542 ruggero.fariello@neurotune.com
Switzerland
 
NCT01444690
NT-004-DIPANAP
No
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