Oral Propanolol for Surgically Inaccessible Cavernous Malformations
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|ClinicalTrials.gov Identifier: NCT03523650|
Recruitment Status : Enrolling by invitation
First Posted : May 14, 2018
Last Update Posted : May 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cavernous Malformations,Cerebral and/or Spinal||Drug: Propranolol Oral Tablet Drug: Placebo Oral Tablet||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||346 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oral Propanolol for Surgically Inaccessible Cerebral and Spinal Cavernous Malformations|
|Actual Study Start Date :||February 7, 2018|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
Experimental: Group 1: Propranolol Group
Group 1: Propranolol - group of randomized patients will receive one propranolol pill tid for 36 months.
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.
Placebo Comparator: Group 2: Placebo Group
Group 2: Placebo - group of randomized patients will receive one placebo pill 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523650
|United States, Virginia|
|Univeristy of Virginia|
|Charlottesville, Virginia, United States, 22903|
|Principal Investigator:||Yashar Kalani, MD, PHD||University of Virginia Medical Center|