Use of Minocicline in Patients With Stroke

March 15, 2012 updated by: Nataly Bedoya, Hospital Universitario Hernando Moncaleano Perdomo

Effect of Minocicline Use in Less Neurologic Sequels in Patients With Stroke

The investigators will evaluate the National Institute of Health Stroke Scale/Score (NIHSS)in patients with stroke, and then give Minocycline 100mg po every 12 hours or placebo for five days, then perform periodic evaluations to determine the status and degree of neurological sequelae developed.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

134

Phase

  • Phase 1

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

  • Colombia
    • Huila
      • Neiva, Huila, Colombia
        • Recruiting
        • University Hospital hernando Moncaleano Perdomo
        • Contact:

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • NIHSS scale greater than 5
  • Onset of symptoms less than 24 hours
  • normal Cranial Tomography(CT)
  • CT evidence of cerebral ischemia
  • Acceptance of study entry

Exclusion Criteria:

  • Hemorrhagic cerebrovascular disease
  • Other neurological diseases
  • Concomitant structural damage
  • History of neurosurgery
  • Known allergy to tetracyclines
  • Concomitant infectious diseases requiring antibiotic treatment.
  • History of Stroke
  • Women pregnant or breast-feeding

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Minocicline
minocicline 100mg oral twice a day for 5 days
Drug: Minocicline
Minocicline 100mg oral twice a day for 5 days
Placebo Comparator: Placebo
Pills filled with vegetal fiber with similar presentation of the drug. Given one pill oral twice a day for five days
Drug: Placebo
Pills with vegetable fibers one pill oral twice a day for five days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the efficacy of minocycline in reducing neurological sequelae in patients with stroke
Time Frame: one year
The researchers evaluated the neurological condition of paralysis, aphasia,and level of consciousness by NIHSS score for each patient with stroke and proceeded to give minocycline or placebo. Then, the assessment was repeated after five and thirty days post treatment to determine whether their neurological sequelae had diminushed.
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Identify the side effects of the intervention administered during the treatment time and 30 days later.
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

Hospital Universitario Hernando Moncaleano Perdomo

Investigators

  • Study Director: Nataly Bedoya, Internist, Universidad Surcolombiana
  • Principal Investigator: Hernan Vargas, Internist, Universidad Surcolombiana
  • Principal Investigator: Hugo Osorio, Internist, Universidad Surcolombiana
  • Principal Investigator: Guillermo Gonzalez, Neurologist, Universidad Surcolombiana
  • Principal Investigator: Javier Saldaña, Epidemiology, Universidad Surcolombiana
  • Principal Investigator: Efrain Amaya, Neurologist, Hospital Hernando Moncaleano Perdomo

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

October 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

March 5, 2012

First Submitted That Met QC Criteria

March 15, 2012

First Posted (Estimate)

March 16, 2012

Study Record Updates

Last Update Posted (Estimate)

March 16, 2012

Last Update Submitted That Met QC Criteria

March 15, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38212050

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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