Use of Minocicline in Patients With Stroke

Phase 1

• Conditions: Stroke; Brain Ischemia; Paralysis
• Interventions: Drug: Minocicline; Drug: Placebo

• Registration Number: NCT01556802
• Lead Sponsor: Hospital Universitario Hernando Moncaleano Perdomo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2011-11
• Status Verified: 2012-03
• Study First Submitted: 2012-03-05
• Study First Submitted QC: 2012-03-15
• Last Update Submitted: 2012-03-15
• Study First Posted: 2012-03-16
• Last Update Posted: 2012-03-16
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minocicline	Minocicline	minocicline 100mg oral twice a day for 5 days
Placebo	Placebo	Pills filled with vegetal fiber with similar presentation of the drug. Given one pill oral twice a day for five days

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Identify the side effects of the intervention administered during the treatment time and 30 days later.	one year

Trial Locations

Locations (1)

University Hospital hernando Moncaleano Perdomo; 🇨🇴 Neiva, Huila, Colombia