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:
Northwell Health
Organization:
Study Overview
Official Title:
An Open-label, Prospective Trial to Determine the Effect(s) of Obesity on the Pharmacokinetic Parameters of Valproic Acid
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: