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| Sponsors and Collaborators: |
University of California, San Francisco National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
| ClinicalTrials.gov Identifier: | NCT00243893 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Aneurysms Arteriovenous Malformations |
Drug: minocycline Drug: doxycycline |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
| Official Title: | Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms |
| Enrollment: | 26 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | October 2008 |
| Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Brain AVMs: Active Comparator
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.
|
Drug: minocycline
Take minocycline 50mg BID x2 years. Labs drawn at baseline, then every-6 months. MRI is done at baseline and completion of study.
Drug: 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: Active Comparator |
Drug: minocycline
Take minocycline 50mg BID x2 years. Labs drawn at baseline, then every-6 months. MRI is done at baseline and completion of study.
Drug: doxycycline
Take doxycycline 50mg BID x2 years. Labs drawn at baseline, then every-6 months. MRI is done at baseline and completion of study.
|
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| Ages Eligible for Study: | 13 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| University of California | |
| San Francisco, California, United States, 94143 | |
| Principal Investigator: | William L. Young, MD | University of California, San Francisco |
More Information
| Responsible Party: | University of California, San Francisco ( William L. Young, M.D. ) |
| Study ID Numbers: | R01NS027713, NS034949 |
| Study First Received: | October 24, 2005 |
| Last Updated: | January 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00243893 History of Changes |
| Health Authority: | United States: Federal Government |
|
giant aneurysms arteriovenous malformations minocycline doxycycline BAVM |
|
Anti-Infective Agents Minocycline Aneurysm Cardiovascular Abnormalities Intracranial Arteriovenous Malformations Nervous System Malformations Vascular Diseases Central Nervous System Diseases Tetracycline Brain Diseases |
Cerebrovascular Disorders Intracranial Arterial Diseases Antimalarials Anti-Bacterial Agents Vascular Malformations Hemangioma Arteriovenous Malformations Congenital Abnormalities Doxycycline |
|
Anti-Infective Agents Antiprotozoal Agents Minocycline Molecular Mechanisms of Pharmacological Action Intracranial Arteriovenous Malformations Nervous System Malformations Brain Diseases Tetracycline Cerebrovascular Disorders Intracranial Arterial Diseases Antimalarials Anti-Bacterial Agents Antiparasitic Agents Therapeutic Uses Vascular Malformations |
Neoplasms, Vascular Tissue Hemangioma Cardiovascular Diseases Congenital Abnormalities Neoplasms by Histologic Type Cardiovascular Abnormalities Aneurysm Central Nervous System Vascular Malformations Nervous System Diseases Vascular Diseases Central Nervous System Diseases Enzyme Inhibitors Pharmacologic Actions Protein Synthesis Inhibitors Neoplasms |
