http://clinicaltrials.gov/ct2/show/NCT01556802?term=minocycline+stroke&rank=5

Use of Minocicline in Patients With Stroke

This study is currently recruiting participants.

Verified March 2012 by Hospital Universitario Hernando Moncaleano Perdomo

First Received on March 5, 2012.   Last Updated on March 15, 2012   History of Changes

Sponsor:	Hospital Universitario Hernando Moncaleano Perdomo
Information provided by  (Responsible Party):	Nataly Bedoya, Hospital Universitario Hernando Moncaleano Perdomo
ClinicalTrials.gov Identifier:	NCT01556802

  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 I

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

Resource links provided by NLM:

MedlinePlus related topics: Paralysis

U.S. FDA Resources 

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

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:

Stroke Cerebral Infarction Brain Ischemia Ischemia Paralysis Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases

Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Neurologic Manifestations Signs and Symptoms

ClinicalTrials.gov processed this record on March 15, 2012

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