Dapsone for Acute Ischemia Stroke Study (DAISY)

June 14, 2010 updated by: Cidat, S.A. de C.V.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
    • Mexico City.
      • Tlalpan, Mexico City., Mexico, 14269
        • Recruiting
        • El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
        • Contact:
        • Principal Investigator:
          • José A Santos, MD
        • Sub-Investigator:
          • Rubén Martínez, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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:
  • DDS
  • diamino-diphenyl sulfone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 days after stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel index
Time Frame: 90 days after stroke
The Barthel Index evaluates the daily-live activities rating in 20 points of functional activities.
90 days after stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cidat, S.A. de C.V.

Collaborators

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Investigators

  • Principal Investigator: Juan A. Nader, MD, Hospital Medica Sur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

August 1, 2010

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

June 14, 2010

First Submitted That Met QC Criteria

June 14, 2010

First Posted (Estimate)

June 15, 2010

Study Record Updates

Last Update Posted (Estimate)

June 15, 2010

Last Update Submitted That Met QC Criteria

June 14, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIDAT-072009-DAA-MC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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