Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2026-02-25 @ 5:48 PM
Study NCT ID:
NCT02993861
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2016-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Anti-epileptic Drugs in Obese Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-02', 'studyFirstSubmitDate': '2016-12-13', 'studyFirstSubmitQcDate': '2016-12-13', 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Steady-state pharmacokinetics area under the curve', 'timeFrame': 'Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)'}, {'measure': 'Steady-state pharmacokinetics maximum concentration', 'timeFrame': 'Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)'}, {'measure': 'Steady-state pharmacokinetics time to reach maximum concentration', 'timeFrame': 'Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)'}, {'measure': 'Steady-state pharmacokinetics oral apparent volume of distribution', 'timeFrame': 'Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)'}, {'measure': 'Steady-state pharmacokinetics half life', 'timeFrame': 'Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)'}, {'measure': 'Steady-state pharmacokinetics oral apparent clearance', 'timeFrame': 'Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)'}, {'measure': 'Steady-state pharmacokinetics absorption rate constant', 'timeFrame': 'Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)'}], 'secondaryOutcomes': [{'measure': 'Serious adverse events', 'timeFrame': 'Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Epilepsy', 'Obese'], 'conditions': ['Epilepsy', 'Obese']}, 'descriptionModule': {'briefSummary': "The study is a prospective, multi-center, open-label clinical trial. Study's purpose is to characterize the pharmacokinetics and safety of four oral anti-epileptics drugs (levetiracetam, valproic acid \\[divalproex sodium ER or immediate release formulation if inadequate enrollment}, topiramate, and oxcarbazepine) in a non-randomized sample of obese children and adolescents. The study's duration will be up to eleven days (up to seven days of screening and four days of pharmacokinetic sampling). Eligible participants ages 2 to 18 years will be identified through outpatient clinic schedules and inpatient admissions at each clinic site. Participants receiving at least one of the study drugs per local standard of care will have pharmacokinetic concentrations in plasma drawn according to the specific dosing schedule for each drug. Other study measures include demographics, BMI, waist/hip ratio, medical history, concomitant medication history, documentation of study drug oral intake, adverse effects, and physical examination. The sample size will include 24 participants for each anti-epileptic drug (total 96)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with epilepsy who are inpatients in local hospital or managed in outpatient settings - community sample.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 2 years to \\< 18 years at the time of enrollment\n* BMI ≥ 95th percentile for age and sex, based on CDC recommendations\n* Informed consent/HIPAA from the parent/legal guardian and assent (as applicable)\n* Receiving ≥ 1 of the study drugs per local standard of care\n\nExclusion Criteria:\n\n* Known pregnancy as determined via interview or test results, if available'}, 'identificationModule': {'nctId': 'NCT02993861', 'briefTitle': 'Pharmacokinetics of Anti-epileptic Drugs in Obese Children', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Pharmacokinetics of Anti-epileptic Drugs in Obese Children', 'orgStudyIdInfo': {'id': 'Pro00070924'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Levetiracetam', 'description': 'Children with epilepsy who are treated with levetiracetam per local standard of care', 'interventionNames': ['Other: Anti-epileptics']}, {'label': 'Valproic Acid', 'description': 'Children with epilepsy who are treated with valproic acid per local standard of care', 'interventionNames': ['Other: Anti-epileptics']}, {'label': 'Topiramate', 'description': 'Children with epilepsy who are treated with topiramate per local standard of care', 'interventionNames': ['Other: Anti-epileptics']}, {'label': 'Oxcarbazepine', 'description': 'Children with epilepsy who are treated with oxcarbazepine per local standard of care', 'interventionNames': ['Other: Anti-epileptics']}], 'interventions': [{'name': 'Anti-epileptics', 'type': 'OTHER', 'armGroupLabels': ['Levetiracetam', 'Oxcarbazepine', 'Topiramate', 'Valproic Acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "The Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '19803', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Nemours Alfred I. DuPont Hospital for Children', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '30324', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Childrens Healthcare of Atlanta', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann and Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville Norton Childrens Hospital', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Health System', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': "Coastal Children's Services", 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '75390-8589', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Kanecia Zimmerman, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Medical Center/Duke Clinical Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christoph P Hornik, MD MPH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'The Emmes Company, LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Christoph P Hornik, MD MPH', 'investigatorAffiliation': 'Duke University'}}}}