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Minocycline Treatment in Acute Hemorrhagic Stroke

This study is not yet open for participant recruitment.
Verified June 2011 by Wolfson Medical Center
Sponsor:
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01388127
First received: July 3, 2011
Last updated: July 5, 2011
Last verified: June 2011
History of Changes
  Purpose

The investigators will perform a double blind controlled study to investigate the efficacy of oral administration of 200 mg minocycline, on the neurological and functional outcome after acute hemorrhagic stroke and the effect on blood brain barrier permeability.


Condition
Poor Performance Status

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Minocycline Treatment in Acute Hemorrhagic Stroke for Evaluation of Treatment Efficacy and Blood Brain Barrier Permeability

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wolfson Medical Center:

Estimated Enrollment: 150
Study Start Date: July 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Minocycline, a semisynthetic second generation derivative of tetracycline, was shown to have a clear beneficial neuroprotective effect in animal models of multiple sclerosis, Parkinson's disease, Huntington's disease and amyotrophic lateral sclerosis. Animal models provide promising evidence of minocycline's ability to improve outcomes in an animal stroke model.

In light of these findings, we will perform a double blind controlled study to investigate the efficacy of oral administration of 200 mg minocycline, on the neurological and functional outcome after acute hemorrhagic stroke and the effect on blood brain barrier permeability.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

150 patients after acute hemorrhagic stroke. Half treated with Minocycline.

Criteria

Inclusion Criteria:

  • Patients with acute hemorrhagic stroke

    1. age > 18
    2. NIHSS score > 5
    3. onset of stroke 6 to 24 hours prior to beginning of treatment. Patients, who arrived within 0 to 6 hours post stroke, were treated with other medications according to the best accepted medical treatment guidelines.

Exclusion Criteria:

  1. Evidence of other disease of the central nervous system, including brain tumor, demyelinating disease, inflammatory disease of the central nervous system, craniotomy in the past, severe brain injuries and benign intracranial hypertension
  2. pre-existing neurological disability
  3. known allergic response to tetracyclines
  4. acute or chronic renal failure
  5. pre-existing infectious disease requiring antibiotic therapy
  6. swallowing difficulties
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01388127

Locations
Israel
Edith Wolfson Medical Center Not yet recruiting
Holon, Israel, 58100
Contact: Yair Lampl, MD     972-3-5028512 ext 8512     y_lampl@hotmail.com    
Principal Investigator: Yair Lampl, MD            
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: Yair Lampl, MD Edith Wolfson Medical Center
  More Information

No publications provided

Responsible Party: Yair Lampl MD, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01388127     History of Changes
Other Study ID Numbers: 0048-11 WOMC
Study First Received: July 3, 2011
Last Updated: July 5, 2011
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
 Hemorrhage
Pathologic Processes
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013