Status:
UNKNOWN
Dapsone for Acute Ischemia Stroke Study
Lead Sponsor:
Cidat, S.A. de C.V.
Collaborating Sponsors:
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Conditions:
Cerebral Stroke
Cerebrovascular Accident, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 territo...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01144650
Start Date
July 1 2009
End Date
November 1 2010
Last Update
June 15 2010
Active Locations (1)
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1
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Tlalpan, Mexico City, Mexico, 14269