Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT03474614 |
Other study ID # |
17-0173-30-12 |
Secondary ID |
|
Status |
Terminated |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
January 24, 2018 |
Est. completion date |
February 11, 2021 |
Study information
Verified date |
April 2024 |
Source |
St. Joseph's Hospital and Medical Center, Phoenix |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.