Use of Minocicline in Patients With Stroke
This study is currently recruiting participants.
Verified March 2012 by Hospital Universitario Hernando Moncaleano Perdomo
First Received on March 5, 2012. Last Updated on March 15, 2012 History of Changes
| Sponsor: | Hospital Universitario Hernando Moncaleano Perdomo |
|---|---|
| Information provided by (Responsible Party): | Nataly Bedoya, Hospital Universitario Hernando Moncaleano Perdomo |
| ClinicalTrials.gov Identifier: | NCT01556802 |
Purpose
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 | Intervention | Phase |
|---|---|---|
| Stroke Brain Ischemia Paralysis | Drug: Minocicline Drug: Placebo | Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Effect of Minocicline Use in Less Neurologic Sequels in Patients With Stroke |
Resource links provided by NLM:
Further study details as provided by Hospital Universitario Hernando Moncaleano Perdomo:
Primary Outcome Measures:
- To determine the efficacy of minocycline in reducing neurological sequelae in patients with stroke [ Time Frame: one year ] [ Designated as safety issue: No ]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. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 134 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | January 2013 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556802
Contacts
| Contact: Nataly Bedoya, md | nata0916@hotmail.com |
Locations
| Colombia | |
| University Hospital hernando Moncaleano Perdomo | Recruiting |
| Neiva, Huila, Colombia | |
| Contact: Nataly Bedoya, Md. nata0916@hotmail.com | |
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 |
More InformationNo publications provided
| Responsible Party: | Nataly Bedoya, Internist, Hospital Universitario Hernando Moncaleano Perdomo |
| ClinicalTrials.gov Identifier: | NCT01556802 History of Changes |
| Other Study ID Numbers: | 38212050 |
| Study First Received: | March 5, 2012 |
| Last Updated: | March 15, 2012 |
| Health Authority: | Colombia: National Institutes of Health |
Keywords provided by Hospital Universitario Hernando Moncaleano Perdomo:
| stroke sequelaes minocicline |
Additional relevant MeSH terms:
| Stroke Cerebral Infarction Brain Ischemia Ischemia Paralysis Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases | Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on March 15, 2012
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