Effect of Oral Propranolol on mRNA Expresssion in Symptomatic Cavernous Malformation

This is a single center, randomized, trial that will enroll twenty (n=20) patients with a
diagnosis of symptomatic cavernous malformations who are planned candidates for surgical
resection by one of the investigators, and who meet all of the inclusion and exclusion
criteria. Patients will be randomized into two groups: A Treatment group of ten (n=10)
patients that will receive oral propranolol at a dose of 60mg per day (one 60mg ER capsule
per day) for 7- to 10-days prior to surgery plus their usual medications, and a Control group
of 10 (n=10) patients will receive only their routine medications. Currently, the only active
treatment alternative for symptomatic cerebral cavernous malformations is surgery.

A control group is required to allow for a semi-quantitative comparison with mRNA and miRNA
levels in the treatment group.

Inclusion Criteria:

1. Subject is at least 18-years of age.

2. Clinical and imaging diagnosis of a symptomatic Isolated cavernous malformation or
Familial cavernous malformation

3. MRI Imaging Grade Type I or Type II (see Table 1)

4. Patient is considered a candidate for surgical resection of their cavernous
malformation

5. Written and informed consent obtained prior to the study enrollment.

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

7. Heart rate greater than 50 beats per minute

8. Systolic blood pressure > 90 mmHg

Exclusion Criteria:

1. Subject is less than 18-years of age.

2. History of allergy to propranolol or other beta blockers.

3. Patient is already taking another beta blocker for cardiac indications.

4. History of asthma presently requiring any active treatment (oral medications or
inhalers).

5. History of cardiac dysfunction (as defined by the New York Heart Association
Functional Classification grade II, III or IV).

6. Heart rate < 50 beats per minute

7. Systolic blood pressure < 90 mmHg

8. History of diabetes and currently on any anti-hyperglycemic medication.

9. Pregnant and lactating women.