Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms
NCT ID: NCT00243893
Last Updated: 2013-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2004-07-31
2008-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Brain AVMs
This trial is to investigate the use of minocycline or doxycycline as medical therapy, can minocycline or doxycycline induce biologically significant changes in the enzyme system thought to be related to spontaneous growth/rupture of these malformations. Finally, can patients safely tolerate these medications over an extended period of time.
minocycline
Take minocycline 50mg BID x2 years. Labs drawn at baseline, then every-6 months. MRI is done at baseline and completion of study.
doxycycline
Take doxycycline 50mg BID x2 years. Labs drawn at baseline, then every-6 months. MRI is done at baseline and completion of study.
Aneurysms
minocycline
Take minocycline 50mg BID x2 years. Labs drawn at baseline, then every-6 months. MRI is done at baseline and completion of study.
doxycycline
Take doxycycline 50mg BID x2 years. Labs drawn at baseline, then every-6 months. MRI is done at baseline and completion of study.
Interventions
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minocycline
Take minocycline 50mg BID x2 years. Labs drawn at baseline, then every-6 months. MRI is done at baseline and completion of study.
doxycycline
Take doxycycline 50mg BID x2 years. Labs drawn at baseline, then every-6 months. MRI is done at baseline and completion of study.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
13 Years
80 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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William L. Young, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California
San Francisco, California, United States
Countries
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References
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Frenzel T, Lee CZ, Kim H, Quinnine NJ, Hashimoto T, Lawton MT, Guglielmo BJ, McCulloch CE, Young WL. Feasibility of minocycline and doxycycline use as potential vasculostatic therapy for brain vascular malformations: pilot study of adverse events and tolerance. Cerebrovasc Dis. 2008;25(1-2):157-63. doi: 10.1159/000113733. Epub 2008 Jan 23.
Related Links
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Related Info
Other Identifiers
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NS034949
Identifier Type: -
Identifier Source: secondary_id
NCT00305994
Identifier Type: -
Identifier Source: nct_alias