Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms - Tabular View

Tracking Information

First Received Date ^ICMJE

October 24, 2005

Last Updated Date

January 3, 2008

Start Date ^ICMJE

July 2004

Estimated Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

MRI will be done baseline and post treatment (2 years).
MMP levels are being followed q 6-mos.
Drug levels are being followed q 6-mos.

Change History

Complete list of historical versions of study NCT00243893 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms

Official Title ^ICMJE

Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms

Brief 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.

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Parallel Assignment

Condition ^ICMJE

Aneurysms
Arteriovenous Malformations

Intervention ^ICMJE

Drug: minocycline
Drug: doxycycline

Study Arms / Comparison Groups

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.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

October 2008

Estimated Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

13 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00243893

Responsible Party

William L. Young, M.D., University of California, San Francisco

Study ID Numbers ^ICMJE

R01NS027713, NS034949

Study Sponsor ^ICMJE

University of California, San Francisco

Collaborators ^ICMJE

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators ^ICMJE

Principal Investigator:

William L. Young, MD

University of California, San Francisco

Information Provided By

National Institute of Neurological Disorders and Stroke (NINDS)

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP