Dapsone for Acute Ischemia Stroke Study
Dapsone for Acute Ischemia Stroke Study
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.
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.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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