Use of Minocicline in Patients With Stroke

Stroke Clinical Trial

Official title:

Effect of Minocicline Use in Less Neurologic Sequels in Patients With Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01556802
• Other study ID #: 38212050
• Status: Recruiting
• Phase: Phase 1
• First received: March 5, 2012
• Last updated: March 15, 2012
• Start date: October 2011
• Est. completion date: January 2013

Study information

• Verified date: March 2012
• Source: Hospital Universitario Hernando Moncaleano Perdomo
• Contact: Nataly Bedoya, md
• Email: nata0916[@]hotmail.com
• Is FDA regulated: No
• Health authority: Colombia: National Institutes of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: January 2013
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Ischemia
• Paralysis
• Stroke

Intervention

Drug:
• Minocicline
Minocicline 100mg oral twice a day for 5 days
• Placebo
Pills with vegetable fibers one pill oral twice a day for five days

Locations

Country	Name	City	State
Colombia	University Hospital hernando Moncaleano Perdomo	Neiva	Huila

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Hernando Moncaleano Perdomo

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one year	No
Secondary	Identify the side effects of the intervention administered during the treatment time and 30 days later.		one year	Yes