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Use of Minocicline in Patients With Stroke

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Nataly Bedoya, Hospital Universitario Hernando Moncaleano Perdomo.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01556802
First Posted: March 16, 2012
Last Update Posted: March 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nataly Bedoya, Hospital Universitario Hernando Moncaleano Perdomo
  Purpose
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.

Condition Intervention Phase
Stroke Brain Ischemia Paralysis Drug: Minocicline Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Minocicline Use in Less Neurologic Sequels in Patients With Stroke

Further study details as provided by Nataly Bedoya, Hospital Universitario Hernando Moncaleano Perdomo:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Identify the side effects of the intervention administered during the treatment time and 30 days later. [ Time Frame: one year ]

Estimated Enrollment: 134
Study Start Date: October 2011
Estimated Study Completion Date: January 2013
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT01556802


Contacts
Contact: Nataly Bedoya, md nata0916@hotmail.com

Locations
Colombia
University Hospital hernando Moncaleano Perdomo Recruiting
Neiva, Huila, Colombia
Contact: Nataly Bedoya, Md.       nata0916@hotmail.com   
Sponsors and Collaborators
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
  More Information

Responsible Party: Nataly Bedoya, Internist, Hospital Universitario Hernando Moncaleano Perdomo
ClinicalTrials.gov Identifier: NCT01556802     History of Changes
Other Study ID Numbers: 38212050
First Submitted: March 5, 2012
First Posted: March 16, 2012
Last Update Posted: March 16, 2012
Last Verified: March 2012

Keywords provided by Nataly Bedoya, Hospital Universitario Hernando Moncaleano Perdomo:
stroke
sequelaes
minocicline

Additional relevant MeSH terms:
Stroke
Ischemia
Paralysis
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms