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Dapsone for Acute Ischemia Stroke Study (DAISY)

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ClinicalTrials.gov Identifier: NCT01144650
Recruitment Status : Unknown
Verified June 2010 by Cidat, S.A. de C.V..
Recruitment status was:  Recruiting
First Posted : June 15, 2010
Last Update Posted : June 15, 2010
Sponsor:
Collaborator:
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Information provided by:
Cidat, S.A. de C.V.

Tracking Information
First Submitted Date  ICMJE June 14, 2010
First Posted Date  ICMJE June 15, 2010
Last Update Posted Date June 15, 2010
Study Start Date  ICMJE July 2009
Estimated Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2010)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2010)
Barthel index [ Time Frame: 90 days after stroke ]
The Barthel Index evaluates the daily-live activities rating in 20 points of functional activities.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dapsone for Acute Ischemia Stroke Study
Official Title  ICMJE Clinical Trial Randomized, Placebo-controlled, Using Dapsone as a Neuroprotector During Acute Ischemia Stroke
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cerebral Stroke
  • Cerebrovascular Accident, Acute
  • Cerebrovascular Stroke
  • Stroke, Acute
  • Stroke
Intervention  ICMJE
  • Drug: Dapsone
    Patients will receive either a single total dose of 250 mg dapsone or placebo IV and oral dosage
    Other Names:
    • diamino-diphenyl sulfone
    • DDS
  • Drug: Placebo
    Patients will receive either a single total dose of 250 mg placebo IV and oral dosage
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Patients will receive either a single total dose of 250 mg placebo IV and oral dosage
    Intervention: Drug: Placebo
  • Experimental: Dapsone
    Patients will receive either a single total dose of 250 mg IV and oral dosage
    Intervention: Drug: Dapsone
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 14, 2010)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2010
Estimated Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01144650
Other Study ID Numbers  ICMJE CIDAT-072009-DAA-MC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Camilo Rios, PhD, Instituto Nacional de Neurologia y Neurocirugia
Study Sponsor  ICMJE Cidat, S.A. de C.V.
Collaborators  ICMJE El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Investigators  ICMJE
Principal Investigator: Juan A. Nader, MD Hospital Medica Sur
PRS Account Cidat, S.A. de C.V.
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP