NCT03474614

Effect of Oral Propranolol on mRNA Expresssion in Symptomatic Cavernous Malformation

Effect of Oral Propranolol on mRNA Expression in Symptomatice Caavernous Malformation

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: St. Joseph's Hospital and Medical Center, Phoenix · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cerebral Cavernous Malformations

Interventions

Type	Name	Description
DRUG	Propranolol	The medication will be administered so that patient receives a minimum of 7- days and maximum of 10-days of treatment with propranolol prior to planned surgical resection of CCM (routine care)
GENETIC	DNA and RNA Analysis	During the operative procedure, a small sample of the patient's blood will be obtained and small (1 to 2cc) tissue sample from the resected cavernous malformation will be collected. The blood and tissue samples will be labeled and stored for subsequent DNA and RNA analysis

Timeline

• Start date: 2018-01-24
• Primary completion: 2021-02-11
• Completion: 2021-02-11
• First posted: 2018-03-22
• Last updated: 2024-04-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study