Use of Minocicline in Patients With Stroke

NCT01556802 | Unknown Phase 1 DMC

• 1 other identifier: 38212050
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Brain Ischemia; Paralysis

Keywords

stroke; sequelaes; minocicline

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Identify the side effects of the intervention administered during the treatment time and 30 days later.

  one year

Study Arms (2)

Minocicline

EXPERIMENTAL

minocicline 100mg oral twice a day for 5 days

Drug: Minocicline

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Minocicline DRUG

Minocicline 100mg oral twice a day for 5 days

Minocicline

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario Hernando Moncaleano Perdomo: lead

Study Sites (1)

University Hospital hernando Moncaleano Perdomo

Neiva, Huila Department, Colombia

RECRUITING

MeSH Terms

Conditions

Stroke; Brain Ischemia; Paralysis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nataly Bedoya, Internist

  Universidad Surcolombiana

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nataly Bedoya, md

CONTACT

nata0916@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internist

Study Record Dates

• First Submitted: March 5, 2012
• First Posted: March 16, 2012
• Study Start: October 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: January 1, 2013
• Last Updated: March 16, 2012

Record last verified: 2012-03

Locations

CO (1)