Clinical Trial Randomized, Placebo-controlled, Using Dapsone as a Neuroprotector During Acute Ischemia Stroke
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Shift across the board of National Institute of Health stroke scale (NIHSS) and Modified Rankin Scale (mRS)
Study Overview
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 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo
Patients will receive either a single total dose of 250 mg placebo IV and oral dosage
Intervention: Placebo (Drug)
Dapsone
Patients will receive either a single total dose of 250 mg IV and oral dosage
Intervention: Dapsone (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Barthel index(90 days after stroke)