Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-30 @ 9:10 PM
Study NCT ID:
NCT00298857
Status:
TERMINATED
Last Update Posted:
2012-07-03
First Post:
2006-03-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacokinetic Study to Compare the Dosing of Valproic Acid in Subjects With Different Body Weights
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014635', 'term': 'Valproic Acid'}], 'ancestors': [{'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 22}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-29', 'studyFirstSubmitDate': '2006-03-02', 'studyFirstSubmitQcDate': '2006-03-02', 'lastUpdatePostDateStruct': {'date': '2012-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the concentration time curve (AUC) from zero time to the 54-hour blood sampling and clearance in obese verses non-obese subjects after taking valproic acid.'}]}, 'conditionsModule': {'keywords': ['Healthy', 'Obesity', 'Pharmacokinetics'], 'conditions': ['Healthy', 'Obesity', 'Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the blood levels of valproic acid in subjects with different body weights and to evaluate whether the pharmacokinetic parameters of this drug is altered in the obese population.', 'detailedDescription': 'Many pharmacologic agents are dosed based on the weight of the patient, and studies are conducted to determine the appropriate doses of drugs for patients with different weights in order to find the safest and most effective dose for various weights. Valproic acid is a commonly used agent for the treatment of epilepsy, as well as migraine headaches and psychiatric disorders. This prospective study is designed to evaluate the effects of obesity on the pharmacokinetic parameters of valproic acid when compared to individuals at their healthy weight.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female age 21-60 years\n* Normal healthy volunteers as per interview at screening\n* Willing and able to provide written informed consent and comply with the study protocol\n\nExclusion Criteria:\n\n* Inability to take oral medications\n* pregnant or lactating females\n* known hypersensitivity to valproic acid\n* BMI less than 18.5 kg/m\\^2\n* BMI between 25 and 29.9 kg/m\\^2, inclusive\n* Taking any drug or dietary supplement within one week prior to study period\n* Consumption of food 6 hours prior to study drug ingestion\n* Know family history or history of urea cycle disorders\n* Past history of pancreatitis\n* Past history of liver disease'}, 'identificationModule': {'nctId': 'NCT00298857', 'briefTitle': 'A Pharmacokinetic Study to Compare the Dosing of Valproic Acid in Subjects With Different Body Weights', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'An Open-label, Prospective Trial to Determine the Effect(s) of Obesity on the Pharmacokinetic Parameters of Valproic Acid', 'orgStudyIdInfo': {'id': '05.02.045'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Valproic acid', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Jewish Medical Center', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}], 'overallOfficials': [{'name': 'Alan Ettinger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Shore - Long Island Jewish Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}