Skip to main content
OpenTrials
Completed

NCT Number: NCT00783523

Influence of MMP on Brain AVM Hemorrhage

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Arteriovenous Malformations Aneurysm Brain Aneurysms Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Cavernous Angiomas Cavernous Sinus Syndromes Central Nervous System Diseases Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hemangioma Hemangioma, Cavernous Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Intracranial Aneurysm Intracranial Arterial Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Vascular Tissue Nervous System Diseases Vascular Diseases Vascular Malformations

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California

San Francisco, California, 94143, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxycycline or Placebo

Drug

Randomized to Doxycycline 100mg 2x/day or Placebo 2x/day for 1 or2-weeks pre-operatively.

Other names: Doxycycline, Placebo

Primary outcomes

  1. 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.

    Time frame: 1 to 2-week pre-operative

Secondary outcomes

  1. Our secondary aims are: (1) To explore whether plasma MMP-9 levels can be used as a marker for MMP-9 inhibition in the vascular malformation lesional tissue

    Time frame: 1 to 2-week pre operative

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Influence of Matrix Metalloproteinase on Brain Arteriovenous Malformation Hemorrhage

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 31, 2008
Registry last updated
Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.