Use of Minocicline in Patients With Stroke

NCT ID: NCT01556802

Last Updated: 2012-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Brain Ischemia Paralysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Minocicline

minocicline 100mg oral twice a day for 5 days

Group Type EXPERIMENTAL

Minocicline

Intervention Type DRUG

Minocicline 100mg oral twice a day for 5 days

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Pills with vegetable fibers one pill oral twice a day for five days

Interventions

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Minocicline

Minocicline 100mg oral twice a day for 5 days

Intervention Type DRUG

Placebo

Pills with vegetable fibers one pill oral twice a day for five days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Hernando Moncaleano Perdomo

OTHER

Sponsor Role lead

Responsible Party

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Nataly Bedoya

Internist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nataly Bedoya, Internist

Role: STUDY_DIRECTOR

Universidad Surcolombiana

Hernan Vargas, Internist

Role: PRINCIPAL_INVESTIGATOR

Universidad Surcolombiana

Hugo Osorio, Internist

Role: PRINCIPAL_INVESTIGATOR

Universidad Surcolombiana

Guillermo Gonzalez, Neurologist

Role: PRINCIPAL_INVESTIGATOR

Universidad Surcolombiana

Javier Saldaña, Epidemiology

Role: PRINCIPAL_INVESTIGATOR

Universidad Surcolombiana

Efrain Amaya, Neurologist

Role: PRINCIPAL_INVESTIGATOR

Hospital Hernando Moncaleano Perdomo

Locations

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University Hospital hernando Moncaleano Perdomo

Neiva, Huila Department, Colombia

Site Status RECRUITING

Countries

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Colombia

Central Contacts

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Nataly Bedoya, md

Role: CONTACT

Facility Contacts

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Nataly Bedoya, Md.

Role: primary

Other Identifiers

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38212050

Identifier Type: -

Identifier Source: org_study_id

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