Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00243893
Other study ID # R01NS027713
Secondary ID NS034949
Status Completed
Phase Phase 1
First received October 24, 2005
Last updated October 8, 2013
Start date July 2004
Est. completion date October 2008

Study information

Verified date October 2013
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Other known NCT identifiers
  • NCT00305994

Recruitment information / eligibility

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

Study Design

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


Related Conditions & MeSH terms


Intervention

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.
doxycycline
Take doxycycline 50mg BID x2 years. Labs drawn at baseline, then every-6 months. MRI is done at baseline and completion of study.

Locations

Country Name City State
United States University of California San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT03306836 - Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 2 N/A
Recruiting NCT03306823 - Exploration of Anticoagulation Program in Cerebral Aneurysm and Arteriovenous Malformations With Hybrid Operation 1 N/A
Completed NCT01347307 - Stereotactic Body Radiotherapy for Spine Tumors N/A
Recruiting NCT02042326 - Prospective Evaluation of the Efficacy of Sirolimus (Rapamune®) in the Treatment of Severe Arteriovenous Malformations Phase 2
Recruiting NCT05477680 - Intraoperative Brain Shift Calculation Study N/A
Recruiting NCT05484219 - Functional Navigation in Surgery of Cerebral Tumors and Vascular Malformations N/A
Recruiting NCT05484245 - Sonography-guided Resection of Brain Mass Lesions N/A
Completed NCT03656211 - Fertility After Diagnosis and Management of Acquired Uterine Arteriovenous Malformation
Completed NCT04246125 - Patient Skin Dose in Interventional Radiology
Recruiting NCT02879071 - Long Term Follow-up After Embolization of Brain Arteriovenous Malformations
Terminated NCT01801488 - Genome-wide Analysis of Single Nucleotide Polymorphisms of Brain Arteriovenous Malformations and Cerebral Aneurysm N/A
Recruiting NCT06259292 - Comprehensive HHT Outcomes Registry of the United States (CHORUS)
Recruiting NCT02098252 - Treatment of Brain AVMs (TOBAS) Study N/A
Completed NCT02378883 - Apollo™ Onyx™ Delivery Microcatheter Post Market Safety Study N/A
Completed NCT00783523 - Influence of MMP on Brain AVM Hemorrhage Phase 1
Recruiting NCT05276934 - Brain Imaging After Non-traumatic Intracranial Hemorrhage (SAVEBRAINPWI)
Recruiting NCT03031873 - Evaluation of Susceptibility-weighted Magnetic Resonance Imaging and 4d-time-resolved Magnetic Resonance Angiography in Brain Arteriovenous Malformations N/A
Withdrawn NCT02079818 - Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System Phase 4
Completed NCT01381952 - Image Quality and Radiation Dose in Angiography N/A
Active, not recruiting NCT05418816 - SelfWrap-Assisted Arteriovenous Fistulas N/A

External Links