Dimiracetam in Painful Neuropathies Affecting AIDS Patients (DIPANAP)

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.

Study Overview

• Status: Unknown
• Conditions: Acquired Immunodeficiency Syndrome
• Intervention / Treatment: Drug: Dimiracetam; Drug: Dimiracetam 25 mg

• Study Type: Interventional
• Enrollment (Anticipated): 244
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • Lugano, Switzerland
    • Neurotune AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity measured on 100 mm VAS	Change from baseline in pain intensity as measured on VAS	71 days
Pain intensity as measured with Total Symptom Score (TSS)	Change from baseline as measured with TSS	71 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Comparison of AE frequency between treatment groups	78 days
Number needed to treat	NNT needed to obtain a >60% pain relief from the initial score recorded on the VAS and TSS at study entry	71 days
CD4+ cell count	comparison of CD4+ cell count vs. baseline within and between treatment groups	78 days
HIV viral load	comparison of HIV viral load vs. screening within and between treatment groups	78 days

Collaborators and Investigators

• Sponsor: Neurotune AG
• Investigators: Study Director: Rugerro Fariello, MD, Neurotune AG

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ANTICIPATED): January 1, 2013
• Study Completion (ANTICIPATED): January 1, 2013

Study Registration Dates

• First Submitted: September 29, 2011
• First Submitted That Met QC Criteria: September 30, 2011
• First Posted (ESTIMATE): October 3, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 3, 2011
• Last Update Submitted That Met QC Criteria: September 30, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: Antiretroviral therapy; Acquired Immunodeficiency Syndrome/complications*; Anti-HIV Agents/adverse effects
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: NT-004-DIPANAP