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Minocycline Treatment in Acute Hemorrhagic Stroke

Sponsor
Wolfson Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01388127
Collaborator
(none)
150
Enrollment
1
Location
12
Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated 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 :
    Jul 1, 2011
    Anticipated Primary Completion Date :
    Jul 1, 2012
    Anticipated Study Completion Date :
    Jul 1, 2012

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 90 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 Edith Wolfson Medical Center Holon Israel 58100

      Sponsors and Collaborators

      • Wolfson Medical Center

      Investigators

      • Principal Investigator: Yair Lampl, MD, Edith Wolfson Medical Center

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01388127
      Other Study ID Numbers:
      • 0048-11 WOMC
      First Posted:
      Jul 6, 2011
      Last Update Posted:
      Jul 6, 2011
      Last Verified:
      Jun 1, 2011
      Additional relevant MeSH terms:
      Hemorrhagic Stroke

      Study Results

      No Results Posted as of Jul 6, 2011