Use of Minocicline in Patients With Stroke

Sponsor

Hospital Universitario Hernando Moncaleano Perdomo (Other)

Overall Status

Unknown status

CT.gov ID

NCT01556802

Collaborator

(none)

134

Enrollment

Location

Arms

Duration (Months)

8.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Brain Ischemia Paralysis	Drug: Minocicline Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

134 participants

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

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Nov 1, 2011

Anticipated Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

To determine the efficacy of minocycline in reducing neurological sequelae in patients with stroke [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. [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital hernando Moncaleano Perdomo	Neiva	Huila	Colombia

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