Influence of MMP on Brain AVM Hemorrhage
NCT00783523 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2013-08-09
Summary
Brain vascular malformations, including arteriovenous malformations (AVM), cavernous malformations (CVM) and aneurysms, are a source of life-threatening risk of intracranial hemorrhage. The etiology and pathogenesis are unknown. There is no medical therapy presently available. Prevention of spontaneous intracerebral hemorrhage (ICH) is the primary reason to treat brain vascular malformations. The goal of this study is to: begin pilot studies to lay the groundwork for future clinical trials to develop medical therapy to decrease ICH risk.
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.
Conditions
- Arteriovenous Malformations
- Cavernous Angiomas
- Brain Aneurysms
Interventions
- DRUG
-
Doxycycline or Placebo
Randomized to Doxycycline 100mg 2x/day or Placebo 2x/day for 1 or2-weeks pre-operatively.
Sponsors & Collaborators
-
University of California, San Francisco
lead OTHER
Principal Investigators
-
Chanhung Lee, MD · University of California, San Francisco
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-03-31
- Primary Completion
- 2010-12-31
- Completion
- 2010-12-31
Countries
- United States
Study Locations
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