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Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms


Phase 1
13 Years
80 Years
Open (Enrolling)
Both
Aneurysms, Arteriovenous Malformations

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Trial Information

Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MRI will be done baseline and post treatment.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

William L. Young, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

R01NS027713

NCT ID:

NCT00243893

Start Date:

July 2004

Completion Date:

October 2008

Related Keywords:

  • Aneurysms
  • Arteriovenous Malformations
  • giant aneurysms
  • arteriovenous malformations
  • minocycline
  • doxycycline
  • BAVM
  • Congenital Abnormalities
  • Aneurysm
  • Arteriovenous Malformations
  • Hemangioma
  • Intracranial Arteriovenous Malformations

Name

Location

University of California San Francisco, California  94108