NCT03523650

Oral Propanolol for Surgically Inaccessible Cavernous Malformations

Oral Propanolol for Surgically Inaccessible Cerebral and Spinal Cavernous Malformations

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 346 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 1 Year – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the role of propranolol as an alternative treatment for cavernous malformation in patients that may not be ideal candidates for surgery.

Detailed description

Patients between the ages of 1 and 80 years of age, that have been diagnosed with a spinal or cerebral cavernous malformation(s) that can not be surgically treated, will be enrolled in this randomized study. All eligible patients will be enrolled in one of two groups. Group 1 will receive oral propranolol tablets 3 times a day for 36 months. Group 2 will receive oral placebo tablets 3 times per day for 36 months. Prior to beginning treatment, all imaging, including MRIs, will be evaluated. During the first visit a blood sample will be collected for genomic analysis. Patients will return to clinic every 6 months. Each time the patient returns to clinic monitoring of how the patient is feeling and evaluation of how the patient is tolerating the propranolol will take place. At the end of the three years, evaluators will determine if the propranolol was able to stop the growth of the cavernous malformation and change the imaging features of the lesion on MRI. Once the study is completed patients will no longer receive the study drug.

Conditions

• Cavernous Malformations,Cerebral and/or Spinal

Interventions

Type	Name	Description
DRUG	Propranolol Oral Tablet	A randomized group of patients with cerebral or spinal cavernous malformations, will receive a Propranolol Oral tablets, tid, for 36 months.
DRUG	Placebo Oral Tablet	A randomized group of patients with cerebral or spinal cavernous malformations, will receive a Placebo Oral Tablet, tid, for 36 months.

Timeline

• Start date: 2018-02-07
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2018-05-14
• Last updated: 2018-05-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study