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 range18 Years
SexALL
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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
✓. Systolic blood pressure \> 90 mmHg
Exclusion criteria
✕. Subject is less than 18-years of age.
✕. History of allergy to propranolol or other beta blockers.
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