Oral Propanolol for Surgically Inaccessible Cavernous Malformations

Patients between the ages of 1 and 80 years of age, that have been diagnosed with a spinal or
cerebral cavernous malformation(s) that can not be surgically treated, will be enrolled in
this randomized study. All eligible patients will be enrolled in one of two groups. Group 1
will receive oral propranolol tablets 3 times a day for 36 months. Group 2 will receive oral
placebo tablets 3 times per day for 36 months. Prior to beginning treatment, all imaging,
including MRIs, will be evaluated. During the first visit a blood sample will be collected
for genomic analysis. Patients will return to clinic every 6 months. Each time the patient
returns to clinic monitoring of how the patient is feeling and evaluation of how the patient
is tolerating the propranolol will take place. At the end of the three years, evaluators will
determine if the propranolol was able to stop the growth of the cavernous malformation and
change the imaging features of the lesion on MRI. Once the study is completed patients will
no longer receive the study drug.

Inclusion Criteria:

1. Diagnosis of isolated or familial cavernous malformation syndrome:

- symptomatic cavernous malformation not amenable to surgical resection.

- familial cavernous malformation with seizure, other neurological symptom or
surgically inaccessible lesion.

2. Written and informed consent obtained prior to study enrollment.

3. Subject is able and willing to return for outpatient visits.

4. Negative pregnancy test at time of enrollment for women and child-bearing potential.

Exclusion Criteria:

1. Age less than 1 year-old.

2. Propranolol allergy or allergy to other b-blockers.

3. Estimated life expectancy of less than 1 year.

4. History of severe anemia, cardiac dysfunction, or diabetes.

5. A psychiatric or substance abuse problem that may interfere with study compliance.

6. Pregnant and lactating women.