Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2025-12-25 @ 2:56 PM
Study NCT ID:
NCT03523650
Status:
UNKNOWN
Last Update Posted:
2018-05-14
First Post:
2018-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Propanolol for Surgically Inaccessible Cavernous Malformations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011433', 'term': 'Propranolol'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 346}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-01', 'studyFirstSubmitDate': '2018-04-13', 'studyFirstSubmitQcDate': '2018-05-01', 'lastUpdatePostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of symptomatic and silent hemorrhages on MRI', 'timeFrame': '36 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Rate of de novo lesion formation; changes in rate of breakthrough seizures or other neurological deficits', 'timeFrame': '36 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cavernous Malformations,Cerebral and/or Spinal']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of isolated or familial cavernous malformation syndrome:\n\n * symptomatic cavernous malformation not amenable to surgical resection.\n * familial cavernous malformation with seizure, other neurological symptom or surgically inaccessible lesion.\n2. Written and informed consent obtained prior to study enrollment.\n3. Subject is able and willing to return for outpatient visits.\n4. Negative pregnancy test at time of enrollment for women and child-bearing potential.\n\nExclusion Criteria:\n\n1. Age less than 1 year-old.\n2. Propranolol allergy or allergy to other b-blockers.\n3. Estimated life expectancy of less than 1 year.\n4. History of severe anemia, cardiac dysfunction, or diabetes.\n5. A psychiatric or substance abuse problem that may interfere with study compliance.\n6. Pregnant and lactating women.'}, 'identificationModule': {'nctId': 'NCT03523650', 'briefTitle': 'Oral Propanolol for Surgically Inaccessible Cavernous Malformations', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Oral Propanolol for Surgically Inaccessible Cerebral and Spinal Cavernous Malformations', 'orgStudyIdInfo': {'id': '20195'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: Propranolol Group', 'description': 'Group 1: Propranolol - group of randomized patients will receive one propranolol pill tid for 36 months.', 'interventionNames': ['Drug: Propranolol Oral Tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2: Placebo Group', 'description': 'Group 2: Placebo - group of randomized patients will receive one placebo pill tid for 36 months.', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'Propranolol Oral Tablet', 'type': 'DRUG', 'description': 'A randomized group of patients with cerebral or spinal cavernous malformations, will receive a Propranolol Oral tablets, tid, for 36 months.', 'armGroupLabels': ['Group 1: Propranolol Group']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'A randomized group of patients with cerebral or spinal cavernous malformations, will receive a Placebo Oral Tablet, tid, for 36 months.', 'armGroupLabels': ['Group 2: Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Univeristy of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'overallOfficials': [{'name': 'Yashar Kalani, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Director of Neurovascular Surgery, Director of Skull Base Surgy and Director of Stroke Center', 'investigatorFullName': 'Yashar Kalani, MD', 'investigatorAffiliation': 'University of Virginia'}}}}