Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms
Recruitment status was Active, not recruiting
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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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms |
- MRI will be done baseline and post treatment. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- MMP levels are being followed q 6-mos. [ Time Frame: Patients called weekly for 1st-3 months, then every 6-months until completion of study ] [ Designated as safety issue: Yes ]
- Drug levels are being followed q 6-mos. [ Time Frame: Patients called weekly for 1st-3 months, then every 6-months until completion of study ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
|
Active Comparator: 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.
|
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.
|
| Active Comparator: Aneurysms |
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.
|
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| Ages Eligible for Study: | 13 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
Publications:
| Responsible Party: | William L. Young, M.D., University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00243893 History of Changes |
| Obsolete Identifiers: | NCT00305994 |
| Other Study ID Numbers: | R01NS027713, NS034949 |
| Study First Received: | October 24, 2005 |
| Last Updated: | February 16, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of California, San Francisco:
|
giant aneurysms arteriovenous malformations minocycline doxycycline BAVM |
Additional relevant MeSH terms:
|
Intracranial Arteriovenous Malformations Congenital Abnormalities Aneurysm Arteriovenous Malformations Hemangioma Vascular Diseases Cardiovascular Diseases Vascular Malformations Cardiovascular Abnormalities Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Central Nervous System Vascular Malformations Nervous System Malformations Intracranial Arterial Diseases Tetracycline Doxycycline Doxycycline hyclate Minocycline Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013