Minocycline Treatment in Acute Hemorrhagic Stroke

NCT ID: NCT01388127

Last Updated: 2011-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Poor Performance Status

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Wolfson Medical Center

Principal Investigators

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Yair Lampl, MD

Role: PRINCIPAL_INVESTIGATOR

Edith Wolfson Medical Center

Locations

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Edith Wolfson Medical Center

Holon, Israel, Israel

Site Status

Countries

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Israel

Facility Contacts

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Yair Lampl, MD

Role: primary

972-3-5028512 ext. 8512

Other Identifiers

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0048-11 WOMC

Identifier Type: -

Identifier Source: org_study_id

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