Cerebral StrokePhase 2/3DAISYNCT01144650
Dapsone for Acute Ischemia Stroke Study
A Phase 2/3 study testing Dapsone in people with Cerebral Stroke and Cerebrovascular Accident, Acute, run by Cidat, S.A. de C.V. at 1 site in Mexico.
Trial summary
The main purpose of the study is to get information about the safety and efficacy of treatment with Dapsone to prevent the disability after ischemic Stroke, in patients diagnosed with anterior territory brain infarct. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Stroke, Cerebrovascular Accident, Acute, Cerebrovascular Stroke
- What is being tested?
- Dapsone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2009to Nov 2010
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with the clinical diagnosis of an acute cerebrovascular event in in the anterior cerebral territory, within the last 12 hours who match the MRI or axial CT image.
- Patients with 4 o more points of the National Institute of Health Stroke Scale (NIHSS)
- Age older than 18 years, both gender
- Non acute cerebrovascular event previous
- Informed consent signed by patient or relatives
Who cannot join
- Diagnosed with recurrent diseases like: heart failure; Myocardial Infarction up 8 weeks before; ventrivular arrhythmia diagnosed by ECG; Second-Degree and Third-Degree Atrioventricular Block; or Long QT Syndrome.
- Pregnancy
- Allergic reactions to sulfa medications
- Patients with kidney failure and hepatic insufficiency
- Deficiency of glucose-6-phosphate dehydrogenase diagnosed
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Tlalpan, Mexico City, 14269
Jorge L Alvarado, MSc, (52-55) 5606-3822 ext. 1060, jorgelaa3@hotmail.com
José A Santos, MD
About this study
Official title: Clinical Trial Randomized, Placebo-controlled, Using Dapsone as a Neuroprotector During Acute Ischemia Stroke
The main purpose of the study is to get information about the safety and efficacy of treatment with Dapsone to prevent the disability after ischemic Stroke, in patients diagnosed with anterior territory brain infarct.
Read the detailed description
Cerebrovascular diseases are the third cause of mortality around the world. Seventy-five percent of the cases correspond to ischemic stroke, and the remaining 25 % to hemorrhagic infarct. The social impact of Stroke is high as it is the first cause for disabilities. After Stroke, several mechanisms of secondary damage act to spread the damage to the surrounding tissue. Those mechanisms include: 1) Excitotoxicity after excitatory amino acids' release 2) Overproduction of free radicals 3) Exacerbated inflammatory response and 4) Apoptosis. Many neuroprotective strategies have been tested to cope with the already mentioned damaging processes with poor clinical results. Many clinical trials have failed to provide neuroprotection to patients after acute stroke. Then, the need for safe drugs with clinical efficacy to prevent Stroke disability consequences is highly recognized. Dapsone is safe and relatively free of adverse reactions, we propose a clinical trial to assess the safety and efficacy of using this drug in patients with ischemic brain stroke.
Methods: A double-blind, placebo-controlled, randomized clinical trial of dapsone is to be conducted from 2009 to 2010. Three-hundred patients with a CT or MRI documented ischemic stroke in the anterior cerebral territory are to be included. Patients with 4 to 20 points of the National Institute of Health Stroke Scale (NIHSS) will be randomly allocated to receive either a single total dose of 250 mg dapsone or placebo within the first 12 h after stroke. For the follow-up, NIHSS on days 0, 2, 7, 30, 60 and 90, modified Rankin scale (mRS) on days 0, 30, 60 and 90, and Barthel index (BI) at day 90, will be all applied. Adverse reactions will be also recorded. The Primary clinical outcome of the patients will be assessed at 90 days after stroke by obtaining the shift analysis from the baseline levels of the scales mRS and NIHSS. Secondary clinical outcome will be the BI at day 90. An interim analysis of the data will be performed when the study have recruited one-hundred patients.
Statistical analysis will be performed with the intention-to-treat approach.
- Conditions
- Cerebral Stroke, Cerebrovascular Accident, Acute, Cerebrovascular Stroke, Stroke, Acute, Stroke
- Being tested
- Dapsone, Placebo
- Keywords
- Dapsone, Cerebrovascular Accident, Acute, Neuroprotection
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapsoneDrug
Also called diamino-diphenyl sulfone, DDS
Patients will receive either a single total dose of 250 mg dapsone or placebo IV and oral dosage
PlaceboDrug
Patients will receive either a single total dose of 250 mg placebo IV and oral dosage
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients will receive either a single total dose of 250 mg placebo IV and oral dosage Receives: Drug: Placebo |
| Dapsone | Experimental | Patients will receive either a single total dose of 250 mg IV and oral dosage Receives: Drug: Dapsone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shift across the board of National Institute of Health stroke scale (NIHSS) and Modified Rankin Scale (mRS)
The NIHSS is a deficit severity scale that assigns 42 points to patients according to the degree of neurologic deficits.
The mRS is a severity scale for the assessment of global disability into 7 points: 0= no disability,1=non-significant disability, 2=slight disability, 3=moderate disability, 4= moderately severe disability, 5= severe disability, 6= dead
Measured: 90 days after stroke
Secondary outcomes (1)
Barthel index
The Barthel Index evaluates the daily-live activities rating in 20 points of functional activities.
Measured: 90 days after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startJul 2009
- Primary completionAug 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral StrokeStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cidat, S.A. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
- Investigators
- Juan A. Nader, MD, Principal investigator, Hospital Medica Sur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144650
- Sponsor's protocol ID
- CIDAT-072009-DAA-MC
- Acronym
- DAISY
- Status last verified
- Jun 2010
- First submitted
- 14 Jun 2010
- Last updated
- 15 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nader-Kawachi J, Gongora-Rivera F, Santos-Zambrano J, Calzada P, Rios C. Neuroprotective effect of dapsone in patients with acute ischemic stroke: a pilot study. Neurol Res. 2007 Apr;29(3):331-4. doi: 10.1179/016164107X159234.
PubMed 17509235
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Randomized, Placebo-controlled, Using Dapsone as a Neuroprotector During Acute Ischemia Stroke
- ClinicalTrials.gov ID
- NCT01144650
- Acronym / sponsor ID
- DAISY / CIDAT-072009-DAA-MC
- Conditions
- Cerebral Stroke, Cerebrovascular Accident, Acute, Cerebrovascular Stroke, Stroke, Acute, Stroke
- Keywords
- Dapsone, Cerebrovascular Accident, Acute, Neuroprotection
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cidat, S.A. de C.V.Industry (pharma, biotech, devices)
- Collaborators
- El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
- Study start
- Jul 2009
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 15 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.
The main purpose of the study is to get information about the safety and efficacy of treatment with Dapsone to prevent the disability after ischemic Stroke, in patients diagnosed with anterior territory brain infarct.
Detailed description
Cerebrovascular diseases are the third cause of mortality around the world. Seventy-five percent of the cases correspond to ischemic stroke, and the remaining 25 % to hemorrhagic infarct. The social impact of Stroke is high as it is the first cause for disabilities. After Stroke, several mechanisms of secondary damage act to spread the damage to the surrounding tissue. Those mechanisms include: 1) Excitotoxicity after excitatory amino acids' release 2) Overproduction of free radicals 3) Exacerbated inflammatory response and 4) Apoptosis. Many neuroprotective strategies have been tested to cope with the already mentioned damaging processes with poor clinical results. Many clinical trials have failed to provide neuroprotection to patients after acute stroke. Then, the need for safe drugs with clinical efficacy to prevent Stroke disability consequences is highly recognized. Dapsone is safe and relatively free of adverse reactions, we propose a clinical trial to assess the safety and efficacy of using this drug in patients with ischemic brain stroke.
Methods: A double-blind, placebo-controlled, randomized clinical trial of dapsone is to be conducted from 2009 to 2010. Three-hundred patients with a CT or MRI documented ischemic stroke in the anterior cerebral territory are to be included. Patients with 4 to 20 points of the National Institute of Health Stroke Scale (NIHSS) will be randomly allocated to receive either a single total dose of 250 mg dapsone or placebo within the first 12 h after stroke. For the follow-up, NIHSS on days 0, 2, 7, 30, 60 and 90, modified Rankin scale (mRS) on days 0, 30, 60 and 90, and Barthel index (BI) at day 90, will be all applied. Adverse reactions will be also recorded. The Primary clinical outcome of the patients will be assessed at 90 days after stroke by obtaining the shift analysis from the baseline levels of the scales mRS and NIHSS. Secondary clinical outcome will be the BI at day 90. An interim analysis of the data will be performed when the study have recruited one-hundred patients.
Statistical analysis will be performed with the intention-to-treat approach.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive either a single total dose of 250 mg placebo IV and oral dosage |
| Dapsone | Experimental | Drug: DapsonePatients will receive either a single total dose of 250 mg IV and oral dosage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with the clinical diagnosis of an acute cerebrovascular event in in the anterior cerebral territory, within the last 12 hours who match the MRI or axial CT image.
- Patients with 4 o more points of the National Institute of Health Stroke Scale (NIHSS)
- Age older than 18 years, both gender
- Non acute cerebrovascular event previous
- Informed consent signed by patient or relatives
Key exclusion criteria (5 listed)
- Diagnosed with recurrent diseases like: heart failure; Myocardial Infarction up 8 weeks before; ventrivular arrhythmia diagnosed by ECG; Second-Degree and Third-Degree Atrioventricular Block; or Long QT Syndrome.
- Pregnancy
- Allergic reactions to sulfa medications
- Patients with kidney failure and hepatic insufficiency
- Deficiency of glucose-6-phosphate dehydrogenase diagnosed
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 |
|---|---|---|
| DapsoneAlso: diamino-diphenyl sulfone, DDSPatients will receive either a single total dose of 250 mg dapsone or placebo IV and oral dosage | Drug | Dapsone |
| PlaceboPatients will receive either a single total dose of 250 mg placebo IV and oral dosage | Drug | Placebo |
Primary outcome
Shift across the board of National Institute of Health stroke scale (NIHSS) and Modified Rankin Scale (mRS)
Time frame: 90 days after stroke
The NIHSS is a deficit severity scale that assigns 42 points to patients according to the degree of neurologic deficits. The mRS is a severity scale for the assessment of global disability into 7 points: 0= no disability,1=non-significant disability, 2=slight disability, 3=moderate disability, 4= moderately severe disability, 5= severe disability, 6= dead
1 secondary outcome
Barthel index
Time frame: 90 days after stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2010.
- Results publication: PubMed 17509235Nader-Kawachi J, Gongora-Rivera F, Santos-Zambrano J, Calzada P, Rios C. Neuroprotective effect of dapsone in patients with acute ischemic stroke: a pilot study. Neurol Res. 2007 Apr;29(3):331-4. doi: 10.1179/016164107X159234.
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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.
Juan A. Nader, MD principal investigator
Hospital Medica Sur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dapsone in people with Cerebral Stroke and Cerebrovascular Accident, Acute, run by Cidat, S.A. de C.V. at 1 site in Mexico.
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 5 inclusion and 5 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 15 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 Mexico. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Rosa I Florville, MD ((52-55) 5171-9005, ines.florville@psicofarma.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shift across the board of National Institute of Health stroke scale (NIHSS) and Modified Rankin Scale (mRS) (time frame: 90 days after stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01144650, which also lists 1 linked publication.
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 15 Jun 2010.