NCT00243893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

October 9, 2013

Status Verified

October 1, 2013

Enrollment Period

4.3 years

First QC Date

October 24, 2005

Last Update Submit

October 8, 2013

Conditions

AneurysmsArteriovenous Malformations

Keywords

giant aneurysmsarteriovenous malformationsminocyclinedoxycyclineBAVM

Outcome Measures

Primary Outcomes (3)

  • MRI will be done baseline and post treatment.

    2 years

  • MMP levels are being followed q 6-mos.

    Patients called weekly for 1st-3 months, then every 6-months until completion of study

  • Drug levels are being followed q 6-mos.

    Patients called weekly for 1st-3 months, then every 6-months until completion of study

Study Arms (2)

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: minocyclineDrug: doxycycline

Aneurysms

ACTIVE COMPARATOR
Drug: minocyclineDrug: doxycycline

Interventions

minocyclineDRUG

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

AneurysmsBrain AVMs
doxycyclineDRUG

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

AneurysmsBrain AVMs

Eligibility Criteria

Age13 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California

San Francisco, California, 94143, United States

Location

Related 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 tolerance. Cerebrovasc Dis. 2008;25(1-2):157-63. doi: 10.1159/000113733. Epub 2008 Jan 23.

    PMID: 18212521RESULT

Related Links

MeSH Terms

Conditions

AneurysmArteriovenous Malformationscyclopia sequence

Interventions

MinocyclineDoxycycline

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesVascular MalformationsCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • William L. Young, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2005

First Posted

October 25, 2005

Study Start

July 1, 2004

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

October 9, 2013

Record last verified: 2013-10

Locations

US(1)