Influence of MMP on Brain AVM Hemorrhage

Completed · Phase 1 · Has a placebo group

Conditions studied: Arteriovenous Malformations, Cavernous Angiomas, Brain Aneurysms

In brief

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.

Key facts

Study ID

NCT00783523

Run by

University of California, San Francisco

People needed

33

Starts

2008-03-01

Expected to finish

2010-12-01

Last updated by the study team

2013-08-09

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California — San Francisco, California, United States

Full record on ClinicalTrials.gov

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