- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03523650
Oral Propanolol for Surgically Inaccessible Cavernous Malformations
May 1, 2018 updated by: Yashar Kalani, MD, University of Virginia
Oral Propanolol for Surgically Inaccessible Cerebral and Spinal Cavernous Malformations
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.
Study Overview
Status
Unknown
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
346
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22903
- Univeristy of Virginia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 months to 78 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1: Propranolol Group
Group 1: Propranolol - group of randomized patients will receive one propranolol pill tid for 36 months.
|
A randomized group of patients with cerebral or spinal cavernous malformations, will receive a Propranolol Oral tablets, tid, for 36 months.
|
Placebo Comparator: Group 2: Placebo Group
Group 2: Placebo - group of randomized patients will receive one placebo pill tid for 36 months.
|
A randomized group of patients with cerebral or spinal cavernous malformations, will receive a Placebo Oral Tablet, tid, for 36 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of symptomatic and silent hemorrhages on MRI
Time Frame: 36 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of de novo lesion formation; changes in rate of breakthrough seizures or other neurological deficits
Time Frame: 36 months
|
The secondary outcome is the rate of de novo lesion formation; changes in rate of breakthrough seizures or other neurological deficits; quality of life measured using the SF-36 at each visit, patient satisfaction with treatment; and the incidence of treatment failure.
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yashar Kalani, MD, PHD, University of Virginia Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 7, 2018
Primary Completion (Anticipated)
January 1, 2019
Study Completion (Anticipated)
January 1, 2019
Study Registration Dates
First Submitted
April 13, 2018
First Submitted That Met QC Criteria
May 1, 2018
First Posted (Actual)
May 14, 2018
Study Record Updates
Last Update Posted (Actual)
May 14, 2018
Last Update Submitted That Met QC Criteria
May 1, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Cardiovascular Abnormalities
- Hemangioma
- Neoplasms, Vascular Tissue
- Nervous System Malformations
- Vascular Malformations
- Central Nervous System Vascular Malformations
- Hemangioma, Cavernous
- Congenital Abnormalities
- Hemangioma, Cavernous, Central Nervous System
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Propranolol
Other Study ID Numbers
- 20195
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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