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Use of Minocicline in Patients With Stroke

Primary Purpose

Stroke, Brain Ischemia, Paralysis

Status
Unknown status
Phase
Phase 1
Locations
Colombia
Study Type
Interventional
Intervention
Minocicline
Placebo
Sponsored by
Hospital Universitario Hernando Moncaleano Perdomo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, sequelaes, minocicline

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital hernando Moncaleano PerdomoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Minocicline

Placebo

Arm Description

minocicline 100mg oral twice a day for 5 days

Pills filled with vegetal fiber with similar presentation of the drug. Given one pill oral twice a day for five days

Outcomes

Primary Outcome Measures

To determine the efficacy of minocycline in reducing neurological sequelae in patients with stroke
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.

Full Information

First Posted
March 5, 2012
Last Updated
March 15, 2012
Sponsor
Hospital Universitario Hernando Moncaleano Perdomo
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1. Study Identification

Unique Protocol Identification Number
NCT01556802
Brief Title
Use of Minocicline in Patients With Stroke
Official Title
Effect of Minocicline Use in Less Neurologic Sequels in Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Hernando Moncaleano Perdomo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Brain Ischemia, Paralysis
Keywords
stroke, sequelaes, minocicline

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Minocicline
Arm Type
Experimental
Arm Description
minocicline 100mg oral twice a day for 5 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Pills filled with vegetal fiber with similar presentation of the drug. Given one pill oral twice a day for five days
Intervention Type
Drug
Intervention Name(s)
Minocicline
Intervention Description
Minocicline 100mg oral twice a day for 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pills with vegetable fibers one pill oral twice a day for five days
Primary Outcome Measure Information:
Title
To determine the efficacy of minocycline in reducing neurological sequelae in patients with stroke
Description
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.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Identify the side effects of the intervention administered during the treatment time and 30 days later.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nataly Bedoya, md
Email
nata0916@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nataly Bedoya, Internist
Organizational Affiliation
Universidad Surcolombiana
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hernan Vargas, Internist
Organizational Affiliation
Universidad Surcolombiana
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hugo Osorio, Internist
Organizational Affiliation
Universidad Surcolombiana
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guillermo Gonzalez, Neurologist
Organizational Affiliation
Universidad Surcolombiana
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Javier Saldaña, Epidemiology
Organizational Affiliation
Universidad Surcolombiana
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Efrain Amaya, Neurologist
Organizational Affiliation
Hospital Hernando Moncaleano Perdomo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital hernando Moncaleano Perdomo
City
Neiva
State/Province
Huila
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nataly Bedoya, Md.
Email
nata0916@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Use of Minocicline in Patients With Stroke

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