Effect of Oral Propranolol on mRNA Expresssion in Symptomatic Cavernous Malformation (NCT03474614) | Clinical Trial Compass
TerminatedPhase 2
Effect of Oral Propranolol on mRNA Expresssion in Symptomatic Cavernous Malformation
Stopped: lack of accrual
United States4 participantsStarted 2018-01-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subject is at least 18-years of age.
. Clinical and imaging diagnosis of a symptomatic Isolated cavernous malformation or Familial cavernous malformation
. MRI Imaging Grade Type I or Type II (see Table 1)
. Patient is considered a candidate for surgical resection of their cavernous malformation
. Written and informed consent obtained prior to the study enrollment.
. Negative pregnancy test at time of enrollment for women of child-bearing potential.
. Heart rate greater than 50 beats per minute
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To measure effects of low-dose oral propranolol on global messenger RNA (mRNA) and microRNA (miRNA) expression in the blood and tissue of patients with CCM
Timeframe: -7 to -10 days until surgery
Trial details
NCT IDNCT03474614
SponsorSt. Joseph's Hospital and Medical Center, Phoenix