A Pharmacokinetic Study to Compare the Dosing of Valproic Acid in Subjects With Different Body Weights

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00298857
Recruitment Status : Terminated (Lack of funding)
First Posted : March 3, 2006
Last Update Posted : July 3, 2012
Information provided by (Responsible Party):
Northwell Health

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.

Condition or disease Intervention/treatment Phase
Healthy Obesity Pharmacokinetics Drug: Valproic acid Phase 4

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 Type : Interventional  (Clinical Trial)
Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Prospective Trial to Determine the Effect(s) of Obesity on the Pharmacokinetic Parameters of Valproic Acid
Study Start Date : March 2006
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male or Female age 21-60 years
  • Normal healthy volunteers as per interview at screening
  • Willing and able to provide written informed consent and comply with the study protocol

Exclusion Criteria:

  • Inability to take oral medications
  • pregnant or lactating females
  • known hypersensitivity to valproic acid
  • BMI less than 18.5 kg/m^2
  • BMI between 25 and 29.9 kg/m^2, inclusive
  • Taking any drug or dietary supplement within one week prior to study period
  • Consumption of food 6 hours prior to study drug ingestion
  • Know family history or history of urea cycle disorders
  • Past history of pancreatitis
  • Past history of liver disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00298857

United States, New York
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Northwell Health
Principal Investigator: Alan Ettinger, MD North Shore - Long Island Jewish Medical Center

Responsible Party: Northwell Health Identifier: NCT00298857     History of Changes
Other Study ID Numbers: 05.02.045
First Posted: March 3, 2006    Key Record Dates
Last Update Posted: July 3, 2012
Last Verified: June 2012

Keywords provided by Northwell Health:

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms
Valproic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs