Acquired Immunodeficiency SyndromePhase 2DIPANAPNCT01444690
Dimiracetam in Painful Neuropathies Affecting AIDS Patients
A Phase 2 study testing Dimiracetam and Dimiracetam 25 mg in people with Acquired Immunodeficiency Syndrome, run by Neurotune AG at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acquired Immunodeficiency Syndrome
- What is being tested?
- Dimiracetam and Dimiracetam 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 244 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2012to Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Acquired Immunodeficiency Syndrome
- Being tested
- Dimiracetam, Dimiracetam 25 mg
- Keywords
- Antiretroviral therapy, Acquired Immunodeficiency Syndrome/complications*, Anti-HIV Agents/adverse effects
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DimiracetamDrug
Capsules for oral administration twice daily
Dimiracetam 25 mgDrug
Inactive dose level in capsules administered orally twice daily
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Dimiracetam 400 mg capsules Receives: Drug: Dimiracetam |
| Pseudo-placebo | Placebo comparator | Dimiracetam 25 mg capsules Receives: Drug: Dimiracetam 25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity measured on 100 mm VAS
Change from baseline in pain intensity as measured on VAS
Measured: 71 days
Pain intensity as measured with Total Symptom Score (TSS)
Change from baseline as measured with TSS
Measured: 71 days
Secondary outcomes (4)
Adverse events
Comparison of AE frequency between treatment groups
Measured: 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
Measured: 71 days
CD4+ cell count
comparison of CD4+ cell count vs. baseline within and between treatment groups
Measured: 78 days
HIV viral load
comparison of HIV viral load vs. screening within and between treatment groups
Measured: 78 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Immunodeficiency SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurotune AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rugerro Fariello, MD, Study director, Neurotune AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444690
- Sponsor's protocol ID
- NT-004-DIPANAP
- Acronym
- DIPANAP
- Status last verified
- Sep 2011
- First submitted
- 29 Sep 2011
- Last updated
- 3 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dimiracetam in Painful Neuropathies Affecting AIDS Patients. A Double-blind, Placebo-controlled, Parallel-group, Randomised, Multi-centre Study
- ClinicalTrials.gov ID
- NCT01444690
- Acronym / sponsor ID
- DIPANAP / NT-004-DIPANAP
- Conditions
- Acquired Immunodeficiency Syndrome
- Keywords
- Antiretroviral therapy, Acquired Immunodeficiency Syndrome/complications*, Anti-HIV Agents/adverse effects
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Neurotune AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 3 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: DimiracetamDimiracetam 400 mg capsules |
| Pseudo-placebo | Placebo comparator | Drug: Dimiracetam 25 mgDimiracetam 25 mg capsules |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DimiracetamCapsules for oral administration twice daily | Drug | Active |
| Dimiracetam 25 mgInactive dose level in capsules administered orally twice daily | Drug | Pseudo-placebo |
Primary outcome
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
4 secondary outcomes
Adverse events
Time frame: 78 days
Number needed to treat
Time frame: 71 days
CD4+ cell count
Time frame: 78 days
HIV viral load
Time frame: 78 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rugerro Fariello, MD study director
Neurotune AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dimiracetam and Dimiracetam 25 mg in people with Acquired Immunodeficiency Syndrome, run by Neurotune AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rugerro Fariello, MD (+41-91-6056542, ruggero.fariello@neurotune.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measured on 100 mm VAS (time frame: 71 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2011.