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
  Purpose

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.


Condition Intervention Phase
Acquired Immunodeficiency Syndrome
Drug: Dimiracetam
Drug: Dimiracetam 25 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Dimiracetam in Painful Neuropathies Affecting AIDS Patients. A Double-blind, Placebo-controlled, Parallel-group, Randomised, Multi-centre Study

Resource links provided by NLM:


Further study details as provided by Neurotune AG:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 244
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Dimiracetam 400 mg capsules
Drug: Dimiracetam
Capsules for oral administration twice daily
Placebo Comparator: Pseudo-placebo
Dimiracetam 25 mg capsules
Drug: Dimiracetam 25 mg
Inactive dose level in capsules administered orally twice daily

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444690

Contacts
Contact: Rugerro Fariello, MD +41-91-6056542 ruggero.fariello@neurotune.com

Locations
Switzerland
Neurotune AG Not yet recruiting
Lugano, Switzerland
Contact: Rugerro Fariello, MD         
Sponsors and Collaborators
Neurotune AG
Investigators
Study Director: Rugerro Fariello, MD Neurotune AG
  More Information

No publications provided

Responsible Party: Neurotune AG
ClinicalTrials.gov Identifier: NCT01444690     History of Changes
Other Study ID Numbers: NT-004-DIPANAP
Study First Received: September 29, 2011
Last Updated: September 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Neurotune AG:
Antiretroviral therapy
Acquired Immunodeficiency Syndrome/complications*
Anti-HIV Agents/adverse effects

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Syndrome
Immunologic Deficiency Syndromes
Disease
Pathologic Processes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 18, 2014