Spots Global Cancer Trial Database for Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex
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Trial Identification
Brief Title: Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex
Official Title: Preventing Epilepsy Using Vigabatrin In Infants With Tuberous Sclerosis Complex (PREVeNT Trial) A Randomized, Double-blind, Placebo-controlled Seizure Prevention Clinical Trial for Infants With TSC
Study ID: NCT02849457
Conditions
Study Description
Brief Summary: Study design is a Phase IIb prospective multi-center, randomized, placebo-controlled, double-blind clinical trial. The goal will be to enroll 80 infants with Tuberous Sclerosis Complex who are less than 6 months of age prior to the onset of their first seizure
Detailed Description: The central hypothesis of this Phase IIb trial is that early identification of electroencephalography (EEG) biomarkers and early treatment versus delayed treatment with vigabatrin in infants with tuberous sclerosis complex (TSC) will have a positive impact on developmental outcomes at 24 months of age. It would also prevent or lower the risk of developing infantile spasms and refractory seizures. This preventative approach would be expected to result in more favorable long-term cognitive, behavioral, developmental and psychiatric outcomes and significantly improve overall quality of life. It is a randomized, double-blind, placebo-controlled clinical trial design. Successful completion of this trial will also advance the field by demonstrating the value of systematic surveillance with EEG in asymptomatic infants with TSC.
Keywords
Eligibility
Minimum Age: 1 Day
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
University of California, Los Angeles, Los Angeles, California, United States
Stanford University, Palo Alto, California, United States
Children's National Medical Center, Washington, District of Columbia, United States
Boston Children's Hospital, Boston, Massachusetts, United States
Beaumont Children's Hospital, Royal Oak, Michigan, United States
Minnesota Epilepsy Group, PA, Saint Paul, Minnesota, United States
Washington University in St. Louis, Saint Louis, Missouri, United States
Duke University, Durham, North Carolina, United States
Cincinnati's Children Hospital Medical Center, Cincinnati, Ohio, United States
The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
University of Texas Health Science Center at Houston, Houston, Texas, United States
Seattle Children's Hospital, Seattle, Washington, United States
Contact Details
Name: Martina Bebin, MD, MPA
Affiliation: University of Alabama at Birmingham
Role: PRINCIPAL_INVESTIGATOR
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