NCT01144650

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

June 15, 2010

Status Verified

June 1, 2010

Enrollment Period

1.1 years

First QC Date

June 14, 2010

Last Update Submit

June 14, 2010

Conditions

Cerebral StrokeCerebrovascular Accident, AcuteCerebrovascular StrokeStroke, AcuteStroke

Keywords

DapsoneCerebrovascular Accident, AcuteNeuroprotection

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Barthel index

    90 days after stroke

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients will receive either a single total dose of 250 mg placebo IV and oral dosage

Drug: Placebo

Dapsone

EXPERIMENTAL

Patients will receive either a single total dose of 250 mg IV and oral dosage

Drug: Dapsone

Interventions

DapsoneDRUG

Patients will receive either a single total dose of 250 mg dapsone or placebo IV and oral dosage

Also known as: diamino-diphenyl sulfone, DDS
Dapsone
PlaceboDRUG

Patients will receive either a single total dose of 250 mg placebo IV and oral dosage

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

Tlalpan, Mexico City, 14269, Mexico

RECRUITING

Related Publications (1)

  • Nader-Kawachi J, Gongora-Rivera F, Santos-Zambrano J, Calzada P, Rios C. Neuroprotective effect of dapsone in patients with acute ischemic stroke: a pilot study. Neurol Res. 2007 Apr;29(3):331-4. doi: 10.1179/016164107X159234.

    PMID: 17509235RESULT

MeSH Terms

Conditions

Stroke

Interventions

Dapsone

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic Chemicals

Study Officials

  • Juan A. Nader, MD

    Hospital Medica Sur

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosa I Florville, MD

CONTACT

(52-55) 5171-9005ines.florville@psicofarma.com.mx

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 14, 2010

First Posted

June 15, 2010

Study Start

July 1, 2009

Primary Completion

August 1, 2010

Study Completion

November 1, 2010

Last Updated

June 15, 2010

Record last verified: 2010-06

Locations

ME(1)