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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
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Cerebral Stroke Cerebrovascular Accident, Acute Cerebrovascular Stroke Stroke, Acute Stroke Drug: Dapsone Drug: Placebo Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Trial Randomized, Placebo-controlled, Using Dapsone as a Neuroprotector During Acute Ischemia Stroke
Study Start Date : July 2009
Estimated Primary Completion Date : August 2010
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Dapsone
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo
Patients will receive either a single total dose of 250 mg placebo IV and oral dosage
Drug: Placebo
Patients will receive either a single total dose of 250 mg placebo IV and oral dosage
Experimental: Dapsone
Patients will receive either a single total dose of 250 mg IV and oral dosage
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

Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Barthel index [ Time Frame: 90 days after stroke ]
    The Barthel Index evaluates the daily-live activities rating in 20 points of functional activities.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144650

Contact: Rosa I Florville, MD (52-55) 5171-9005 ines.florville@psicofarma.com.mx

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez Recruiting
Tlalpan, Mexico City., Mexico, 14269
Contact: Jorge L Alvarado, MSc    (52-55) 5606-3822 ext 1060    jorgelaa3@hotmail.com   
Principal Investigator: José A Santos, MD         
Sub-Investigator: Rubén Martínez, MD         
Sponsors and Collaborators
Cidat, S.A. de C.V.
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
Principal Investigator: Juan A. Nader, MD Hospital Medica Sur
More Information

Responsible Party: Camilo Rios, PhD, Instituto Nacional de Neurologia y Neurocirugia
ClinicalTrials.gov Identifier: NCT01144650     History of Changes
Other Study ID Numbers: CIDAT-072009-DAA-MC
First Posted: June 15, 2010    Key Record Dates
Last Update Posted: June 15, 2010
Last Verified: June 2010

Keywords provided by Cidat, S.A. de C.V.:
Cerebrovascular Accident, Acute

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents