Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00243893
• Date of registration: 24/10/2005
• Prospective Registration: No
• Primary sponsor: University of California, San Francisco
• Public title: Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms
• Scientific title: Tetracycline-Derivatives for Treatment of Cerebral Arteriovenous Malformations and Aneurysms
• Date of first enrolment: July 2004
• Target sample size: 26
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00243893
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: William L. Young, MD
• Affiliation: University of California, San Francisco

Key inclusion & exclusion criteria

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



Age minimum: 13 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Aneurysms

Arteriovenous Malformations

Intervention(s)

Drug: minocycline

Drug: doxycycline

Primary Outcome(s)

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]

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]

MRI will be done baseline and post treatment. [Time Frame: 2 years]

Secondary ID(s)

NS034949

R01NS027713

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute of Neurological Disorders and Stroke (NINDS)