Oral Propanolol for Surgically Inaccessible Cavernous Malformations

NCT03523650 | Unknown Phase 1 FDA Drug

• 1 other identifier: 20195
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

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.

Conditions

Cavernous Malformations,Cerebral and/or Spinal

Outcome Measures

Primary Outcomes (1)

• Number of symptomatic and silent hemorrhages on MRI

  Using MRI imaging the size of the cavernous malformation will be measured. The primary outcome is the number of symptomatic and silent hemorrhages as assessed by review of a fine-cut, axial T2-weighted MRI obtained at each visit.

  36 months

Secondary Outcomes (1)

• Rate of de novo lesion formation; changes in rate of breakthrough seizures or other neurological deficits

  36 months

Study Arms (2)

Group 1: Propranolol Group

EXPERIMENTAL

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

Drug: Propranolol Oral Tablet

Group 2: Placebo Group

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

Propranolol Oral Tablet DRUG

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

Group 1: Propranolol Group

Placebo Oral Tablet DRUG

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

Group 2: Placebo Group

Eligibility Criteria

• Age: 1 Year - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Written and informed consent obtained prior to study enrollment.
• Subject is able and willing to return for outpatient visits.
• Negative pregnancy test at time of enrollment for women and child-bearing potential.

You may not qualify if:

• Age less than 1 year-old.
• Propranolol allergy or allergy to other b-blockers.
• Estimated life expectancy of less than 1 year.
• History of severe anemia, cardiac dysfunction, or diabetes.
• A psychiatric or substance abuse problem that may interfere with study compliance.
• Pregnant and lactating women.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

Univeristy of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Interventions

Propranolol

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Yashar Kalani, MD, PHD

  University of Virginia Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director of Neurovascular Surgery, Director of Skull Base Surgy and Director of Stroke Center

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: May 14, 2018
• Study Start: February 7, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: May 14, 2018

Record last verified: 2018-05

Locations

US (1)