NeuropathyPhase 2NCT01135251
Safety and Preliminary Evidence of Efficacy of Escalating Doses of Dimiracetam in AIDS Patients With Painful Neuropathy
A Phase 2 study testing dimiracetam and sugar pill in people with Neuropathy and AIDS, run by Neurotune AG at 1 site in South Africa.
Trial summary
One hundred consenting AIDS patients suffering from treatment induced painful neuropathy will be blindly randomize to Active and Placebo groups (ratio A/P = 3/2 and will receive increasing oral doses of dimiracetam starting from 400 mg b.i.d. and doubling the dose every two weeks until a maximum of 1600 mg b.i.d. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neuropathy, AIDS
- What is being tested?
- dimiracetam and sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteSouth Africa
- Study dates
- Oct 2009to Mar 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male and female aged 18-65 years;
- females of child-bearing potential only if using a medically accepted method of contraception with a second method of birth control, medically prescribed intrauterine device (IUD), or double barrier method (condom in combination with spermicidal) prior to screening and agreeing to continue its use during the whole duration of the study;
- HIV-positive patients treated with ARTs;
- CD4+ cell count > 200/L at the screening;
- patients affected by neuropathic pain caused by ARTs;
- 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;
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- 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;
- signed written informed consent prior to inclusion in the study
Who cannot join
- pregnant or lactating females;
- patients with neuropathic pain due to other factors than the ARTs; any clinically significant underlying disease, according to the Investigator's clinical judgement;
- history of psychosis (e.g. schizophrenia or psychotic depression) or major depression ;
- any current 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 in the neuropathic pain). Use of an investigational drug other than dimiracetam during the study is not permitted;
- 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;
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- 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 (defined according to USDA dietary guidelines) or drug abuse during the last 3 months prior to screening;
- 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: A Double Blind, Parallel-group, Randomized Placebo Controlled, Multicentre Exploratory Study of Dimiracetam in Treatment Induced Painful Neuropathy in Patients With HIV Infection
One hundred consenting AIDS patients suffering from treatment induced painful neuropathy will be blindly randomize to Active and Placebo groups (ratio A/P = 3/2 and will receive increasing oral doses of dimiracetam starting from 400 mg b.i.d. and doubling the dose every two weeks until a maximum of 1600 mg b.i.d. Escalation to the the higher dose is allowed only if the previous dose did not cause tolerability problems. The highest reached dose will be maintained for a total of 8 week treatment. Patients must have a self evaluated pain of at least 4 on a 10 cm visual analog scale (VAS). Primary end point of the study will be the number of Adverse Events (AEs) reported in the placebo versus the active group. Preliminary evidence of efficacy will be sought by comparing active and placebo group as to the intensity of their pain at study onset and at study end. The pain will be evaluated by the VAS the Total Symptoms Score and the Clinical Global Impression
- Conditions
- Neuropathy, AIDS
- Being tested
- dimiracetam, sugar pill
- Keywords
- Neuropathic pain, AIDS, Dimiracetam, Treatment related painful neuropathy in AIDS patients
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dimiracetamDrug
400 mg capsules for oral use to be administered twice a day for a total of 8 weeks
sugar pillDrug
capsules containing 400 mg of inert material will be orally administered twice a day, one pill for 2 weeks, 2 pills for other 2 weeks and 4 pills for the last 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| dimiracetam | Experimental | Capsules containing 400 mg of dimiracetam will be administered orally, twice a day for 8 weeks in ascending schedule, contingent on tolerability of the previous dose, as follows: 1 capsule for two weeks (800mg/day), two capsules for the next two weeks (1600mg/day)and 4 capsules for the final 4 weeks (3200mg/day). Receives: Drug: dimiracetam |
| sugar pill | Placebo comparator | capsules containing 400 mg of inert material will be orally administered twice a day with the same modalities used for the dimiracetam arm: one capsule for 2 weeks, 2 capsules for another 2 weeks and 4 capsules for 4 weeks Receives: Drug: sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and preliminary evidence of efficacy
Measured: August 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startOct 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuropathyStudies 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
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurotune AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A., Triclinium Clinical Trial Project Management (Pty) Ltd.
- Investigators
- Ruggero G Fariello, MD FAAN, Study director, Neurotune AGDaniel R Malan, MD, Principal investigator, Triple Research, Port Elizabeth SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135251
- Sponsor's protocol ID
- CRO-08-94/NT-11624/003
- Status last verified
- Jun 2010
- First submitted
- 1 Jun 2010
- Last updated
- 2 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Parallel-group, Randomized Placebo Controlled, Multicentre Exploratory Study of Dimiracetam in Treatment Induced Painful Neuropathy in Patients With HIV Infection
- ClinicalTrials.gov ID
- NCT01135251
- Acronym / sponsor ID
- CRO-08-94/NT-11624/003
- Conditions
- Neuropathy, AIDS
- Keywords
- Neuropathic pain, AIDS, Dimiracetam, Treatment related painful neuropathy in AIDS patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Neurotune AGIndustry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A., Triclinium Clinical Trial Project Management (Pty) Ltd.
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 2 Jun 2010 (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.
One hundred consenting AIDS patients suffering from treatment induced painful neuropathy will be blindly randomize to Active and Placebo groups (ratio A/P = 3/2 and will receive increasing oral doses of dimiracetam starting from 400 mg b.i.d. and doubling the dose every two weeks until a maximum of 1600 mg b.i.d. Escalation to the the higher dose is allowed only if the previous dose did not cause tolerability problems. The highest reached dose will be maintained for a total of 8 week treatment. Patients must have a self evaluated pain of at least 4 on a 10 cm visual analog scale (VAS). Primary end point of the study will be the number of Adverse Events (AEs) reported in the placebo versus the active group. Preliminary evidence of efficacy will be sought by comparing active and placebo group as to the intensity of their pain at study onset and at study end. The pain will be evaluated by the VAS the Total Symptoms Score and the Clinical Global Impression
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dimiracetam | Experimental | Drug: dimiracetamCapsules containing 400 mg of dimiracetam will be administered orally, twice a day for 8 weeks in ascending schedule, contingent on tolerability of the previous dose, as follows: 1 capsule for two weeks (800mg/day), two capsules for the next two weeks (1600mg/day)and 4 capsules for the final 4 weeks (3200mg/day). |
| sugar pill | Placebo comparator | Drug: sugar pillcapsules containing 400 mg of inert material will be orally administered twice a day with the same modalities used for the dimiracetam arm: one capsule for 2 weeks, 2 capsules for another 2 weeks and 4 capsules for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- male and female aged 18-65 years;
- females of child-bearing potential only if using a medically accepted method of contraception with a second method of birth control, medically prescribed intrauterine device (IUD), or double barrier method (condom in combination with spermicidal) prior to screening and agreeing to continue its use during the whole duration of the study;
- HIV-positive patients treated with ARTs;
- CD4+ cell count > 200/L at the screening;
- patients affected by neuropathic pain caused by ARTs;
Key exclusion criteria (11 listed)
- pregnant or lactating females;
- patients with neuropathic pain due to other factors than the ARTs; any clinically significant underlying disease, according to the Investigator's clinical judgement;
- history of psychosis (e.g. schizophrenia or psychotic depression) or major depression ;
- any current 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 in the neuropathic pain). Use of an investigational drug other than dimiracetam during the study is not permitted;
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 |
|---|---|---|
| dimiracetam400 mg capsules for oral use to be administered twice a day for a total of 8 weeks | Drug | dimiracetam |
| sugar pillcapsules containing 400 mg of inert material will be orally administered twice a day, one pill for 2 weeks, 2 pills for other 2 weeks and 4 pills for the last 4 weeks. | Drug | sugar pill |
Primary outcome
safety and preliminary evidence of efficacy
Time frame: August 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2010.
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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.
Ruggero G Fariello, MD FAAN study director
Neurotune AG
Daniel R Malan, MD principal investigator
Triple Research, Port Elizabeth SA
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 sugar pill in people with Neuropathy and AIDS, run by Neurotune AG at 1 site in South Africa.
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 11 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: finished, as of the sponsor's last update on 2 Jun 2010. 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 South Africa. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and preliminary evidence of efficacy (time frame: August 2010). 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 2 Jun 2010.