Study Results
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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COMPLETED
PHASE1
33 participants
INTERVENTIONAL
2008-03-31
2010-12-31
Brief Summary
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Matrix metalloproteinases (MMPs) regulate the extracellular matrix in association with various hemorrhagic brain disorders. MMP-9 has been most consistently associated with vascular wall instability and hemorrhagic brain disorders. Doxycycline, a non-specific MMP inhibitor, may enhance vascular stability, thus reducing the risk of spontaneous hemorrhage in brain vascular malformations by decreasing MMP-9 activity.
Detailed Description
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* Depending on enrollment/surgery date, patients will take medication either one to two weeks before surgery. Patients will be assigned to a treatment group according to a random table.
* Each patient will be initially provided with a 1 or 2-week supply of drug in blister packs. The patient will take the final dose of study drug on the morning of surgery.
Baseline labs will be obtained and then again at time of surgery along with a piece of surgical tissue.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
DOUBLE
Study Groups
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Doxycycline
Patients undergoing elective vascular malformation surgery will receive doxycycline100 mg twice a day, a dose shown to effectively decrease MMP or placebo, treatment for two weeks prior to surgery
Doxycycline or Placebo
Randomized to Doxycycline 100mg 2x/day or Placebo 2x/day for 1 or2-weeks pre-operatively.
Placebo
Patients undergoing elective vascular malformation surgery will receive doxycycline100 mg twice a day, a dose shown to effectively decrease MMP or placebo, treatment for two weeks prior to surgery
Doxycycline or Placebo
Randomized to Doxycycline 100mg 2x/day or Placebo 2x/day for 1 or2-weeks pre-operatively.
Interventions
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Doxycycline or Placebo
Randomized to Doxycycline 100mg 2x/day or Placebo 2x/day for 1 or2-weeks pre-operatively.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female patients of child bearing age using barrier-type birth control
* Creatinine no greater than 2.0 mg/di
* Alanine aminotransferase (ALT) no greater than 2 times upper limit of normal
* WBC count at least 3,800/mm3
* BMI within 50% of normal
Exclusion Criteria
* Unstable medical illness (unstable angina, advanced cancer, etc) over the last 30 days
* Female patients of child-bearing age not using effective birth control (barrier)
* History of vestibular disease (except benign positional vertigo)
* History of noncompliance with treatment or other experimental protocols
* Patients taking other antibiotics
* History of systemic lupus erythematosis
* Patients who are immunocompromised Patients with clinically significant hepatic dysfunction
13 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Chanhung Lee, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California
San Francisco, California, United States
Countries
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Other Identifiers
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AHA #0730360N
Identifier Type: -
Identifier Source: secondary_id
H42145-30334-02
Identifier Type: -
Identifier Source: org_study_id