Dapsone for Acute Ischemia Stroke Study

Stroke Clinical Trial

— DAISY  

Official title:

Clinical Trial Randomized, Placebo-controlled, Using Dapsone as a Neuroprotector During Acute Ischemia Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01144650
• Other study ID #: CIDAT-072009-DAA-MC
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: June 14, 2010
• Last updated: June 14, 2010
• Start date: July 2009
• Est. completion date: November 2010

Study information

• Verified date: June 2010
• Source: Cidat, S.A. de C.V.
• Contact: Rosa I Florville, MD
• Phone: (52-55) 5171-9005
• Email: ines.florville[@]psicofarma.com.mx
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cerebral Stroke
• Cerebrovascular Accident, Acute
• Cerebrovascular Stroke
• Stroke
• Stroke, Acute

Intervention

Drug:
• Dapsone
Patients will receive either a single total dose of 250 mg dapsone or placebo IV and oral dosage
• Placebo
Patients will receive either a single total dose of 250 mg placebo IV and oral dosage

Locations

Country	Name	City	State
Mexico	El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez	Tlalpan	Mexico City.

Sponsors (2)

Lead Sponsor	Collaborator
Cidat, S.A. de C.V.	El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

Nader-Kawachi J, Góngora-Rivera F, Santos-Zambrano J, Calzada P, Ríos C. Neuroprotective effect of dapsone in patients with acute ischemic stroke: a pilot study. Neurol Res. 2007 Apr;29(3):331-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	90 days after stroke	No
Secondary	Barthel index	The Barthel Index evaluates the daily-live activities rating in 20 points of functional activities.	90 days after stroke	No