Oral Propanolol for Surgically Inaccessible Cavernous Malformations

NCT ID: NCT03523650

Last Updated: 2018-05-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-07
• Study Completion Date: 2019-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1: Propranolol Group

Group 1: Propranolol - group of randomized patients will receive one propranolol pill tid for 36 months.

Group Type: EXPERIMENTAL

Propranolol Oral Tablet

Intervention Type: DRUG

A randomized group of patients with cerebral or spinal cavernous malformations, will receive a Propranolol Oral tablets, tid, for 36 months.

Group 2: Placebo Group

Group 2: Placebo - group of randomized patients will receive one placebo pill tid for 36 months.

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

A randomized group of patients with cerebral or spinal cavernous malformations, will receive a Placebo Oral Tablet, tid, for 36 months.

Interventions

Propranolol Oral Tablet

A randomized group of patients with cerebral or spinal cavernous malformations, will receive a Propranolol Oral tablets, tid, for 36 months.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of isolated or familial cavernous malformation syndrome:

• symptomatic cavernous malformation not amenable to surgical resection.
• familial cavernous malformation with seizure, other neurological symptom or surgically inaccessible lesion.

2. Written and informed consent obtained prior to study enrollment.

3. Subject is able and willing to return for outpatient visits.

4. Negative pregnancy test at time of enrollment for women and child-bearing potential.

Exclusion Criteria

1. Age less than 1 year-old.

2. Propranolol allergy or allergy to other b-blockers.

3. Estimated life expectancy of less than 1 year.

4. History of severe anemia, cardiac dysfunction, or diabetes.

5. A psychiatric or substance abuse problem that may interfere with study compliance.

6. Pregnant and lactating women.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Yashar Kalani, MD

Co-Director of Neurovascular Surgery, Director of Skull Base Surgy and Director of Stroke Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yashar Kalani, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia Medical Center

Locations

Univeristy of Virginia

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

20195

Identifier Type: -

Identifier Source: org_study_id