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Minocycline Treatment in Acute Hemorrhagic Stroke (Minocycline)

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ClinicalTrials.gov Identifier: NCT01388127
Recruitment Status : Unknown
Verified June 2011 by Wolfson Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 6, 2011
Last Update Posted : July 6, 2011
Sponsor:
Information provided by:
Wolfson Medical Center

Brief Summary:
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 or disease
Poor Performance Status

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.


Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Minocycline Treatment in Acute Hemorrhagic Stroke for Evaluation of Treatment Efficacy and Blood Brain Barrier Permeability
Study Start Date : July 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yair Lampl MD, Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT01388127     History of Changes
Other Study ID Numbers: 0048-11 WOMC
First Posted: July 6, 2011    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents