Use of Minocicline in Patients With Stroke

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Hospital Universitario Hernando Moncaleano Perdomo.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Nataly Bedoya, Hospital Universitario Hernando Moncaleano Perdomo
ClinicalTrials.gov Identifier:
NCT01556802
First received: March 5, 2012
Last updated: March 15, 2012
Last verified: March 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Minocicline Use in Less Neurologic Sequels in Patients With Stroke

Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Nataly Bedoya, Internist, Hospital Universitario Hernando Moncaleano Perdomo
ClinicalTrials.gov Identifier: NCT01556802     History of Changes
Other Study ID Numbers: 38212050
Study First Received: March 5, 2012
Last Updated: March 15, 2012
Health Authority: Colombia: National Institutes of Health

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

Additional relevant MeSH terms:
Brain Ischemia
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014