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Influence of Matrix Metalloproteinase on Brain Arteriovenous Malformation Hemorrhage


N/A
13 Years
N/A
Not Enrolling
Both
Arteriovenous Malformations, Cavernous Angiomas, Brain Aneurysms

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Trial Information

Influence of Matrix Metalloproteinase on Brain Arteriovenous Malformation Hemorrhage


- Doses will be randomized by the Pharmacy Department at UCSF for Doxycycline 100 mg/BID
and Placebo BID. These will be prepared in blister-packs.

- 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.


Inclusion Criteria:



- 13 years or older

- 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:

- Allergy to tetracycline

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Our primary aim is to perform a pilot study to document the effect of doxycycline therapy to decrease MMP expression in the vascular malformation tissue.

Outcome Time Frame:

1 to 2-week pre-operative

Safety Issue:

No

Principal Investigator

Chanhung Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Institutional Review Board

Study ID:

H42145-30334-02

NCT ID:

NCT00783523

Start Date:

March 2008

Completion Date:

December 2010

Related Keywords:

  • Arteriovenous Malformations
  • Cavernous Angiomas
  • Brain Aneurysms
  • Congenital Abnormalities
  • Aneurysm
  • Arteriovenous Malformations
  • Hemangioma
  • Hemorrhage
  • Intracranial Aneurysm
  • Hemangioma, Cavernous

Name

Location
University of California San Francisco, California  94108