Status:
COMPLETED
Supporting Treatment Adherence Regimens in Pediatric Epilepsy: The STAR Trial
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Epilepsy
Eligibility:
All Genders
2-12 years
Phase:
NA
Brief Summary
Fifty-eight percent of children with new-onset epilepsy do not take their antiepileptic drugs (AEDs) as prescribed (i.e., non-adherence). Non-adherence, which is modifiable, is associated with continu...
Detailed Description
Non-adherence to antiepileptic drugs (AEDs) is a common (i.e., 58% of patients have some level of non-adherence) and previously under-recognized problem for young children with newly diagnosed epileps...
Eligibility Criteria
Inclusion
- ages 2-12 years
- diagnosis of epilepsy within approximately 6 months
- only one prescribed AED
- family lives \< 75 miles from Cincinnati Children's Hospital Medical Center (CCHMC)
- ability to read English
Exclusion
- comorbid medical disorders requiring daily medication
- parent-reported significant developmental delays (e.g. Autism)
- liquid AED formulation due to electronic monitoring incompatibility.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01851057
Start Date
April 1 2013
End Date
December 1 2019
Last Update
January 23 2020
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229