Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms
Information source: National Institute of Neurological Disorders and Stroke (NINDS)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Aneurysms; Arteriovenous Malformations
Intervention: minocycline (Drug); doxycycline (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s):
William L. Young, MD, Principal Investigator, Affiliation: University of California, San Francisco
Summary
The purpose of this pilot study is to investigate the use of minocycline and doxycycline as
medical therapy for inoperable or partially treated arteriovenous malformations (AVMs) and
giant aneurysms.
Clinical Details
Official title: Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms
Study design: Treatment, Randomized, Open Label, Parallel Assignment
Primary outcome: MRI will be done baseline and post treatment.MMP levels are being followed q 6-mos. Drug levels are being followed q 6-mos.
Detailed description:
Arteriovenous malformations (AVMs) are a treatable cause of stroke in young adults. The
processes by which AVMs and giant aneurysms grow in size and spontaneously bleed are unknown.
The primary reason to treat AVMs and aneurysms is to guard against intracranial bleeding.
This pilot study will examine the use of two common antibiotics—minocycline and
doxycycline—as medical therapy for inoperable or partially treated AVMs and giant aneurysms.
These drugs, which are tetracycline derivatives, can reduce the levels of a family of
enzymes, called matrix metalloproteases, that degrade tissue and thereby cause a reduction in
the risk of spontaneous bleeding from AVMs or aneurysm—which is the main cause of stroke
associated with these disorders. The enzymes can contribute to weaknesses in the wall of
blood vessels and may increase the risk of the vessel wall rupturing and causing spontaneous
bleeding.
This trial also will show that taking minocycline and doxycycline over an extended period in
this patient population is safe and well tolerated. Results from this study could help plan
future studies to benefit patients with abnormal blood vessels prone to bleeding in their
brains.
Eligibility
Minimum age: 13 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Giant aneurysms or brain arteriovenous malformations (BAVM)
- Female patients of child bearing age using effective birth control, males
- Creatinine no greater than 2. 0 mg/dl
- ALT no greater than 2 times upper limit of control
Exclusion Criteria:
- Unstable medical illness
- Contraindications to Tetracycline
- History of vestibular disease, (except benign positional vertigo)
- Prior tetracycline use within 2 mos of baseline visit.
- History of noncompliance with treatment or other protocols
- History of systemic lupus
- Patients not eligible for MRI
Locations and Contacts
University of California, San Francisco, California 94143, United States
Additional Information
Starting date: July 2004
Ending date: October 2008
Last updated: January 3, 2008
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