Arteriovenous Malformations Clinical Trial
Official title:
Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | October 2008 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 13 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of California | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
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 tole — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MRI will be done baseline and post treatment. | 2 years | Yes | |
Primary | MMP levels are being followed q 6-mos. | Patients called weekly for 1st-3 months, then every 6-months until completion of study | Yes | |
Primary | Drug levels are being followed q 6-mos. | Patients called weekly for 1st-3 months, then every 6-months until completion of study | Yes |
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