HealthyPhase 4NCT00298857
A Pharmacokinetic Study to Compare the Dosing of Valproic Acid in Subjects With Different Body Weights
A Phase 4 study testing Valproic acid in people with Healthy and Obesity, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Obesity, Pharmacokinetics
- What is being tested?
- Valproic acid
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Mar 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
About this study
Official title: An Open-label, Prospective Trial to Determine the Effect(s) of Obesity on the Pharmacokinetic Parameters of Valproic Acid
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.
Read the 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.
- Conditions
- Healthy, Obesity, Pharmacokinetics
- Being tested
- Valproic acid
- Keywords
- Healthy, Obesity, Pharmacokinetics
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valproic acidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2006 (estimated)
- Study startMar 2006
- Study completionMar 2007
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan Ettinger, MD, Principal investigator, North Shore - Long Island Jewish Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298857
- Sponsor's protocol ID
- 05.02.045
- Status last verified
- Jun 2012
- First submitted
- 2 Mar 2006
- Last updated
- 3 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Prospective Trial to Determine the Effect(s) of Obesity on the Pharmacokinetic Parameters of Valproic Acid
- ClinicalTrials.gov ID
- NCT00298857
- Acronym / sponsor ID
- 05.02.045
- Conditions
- Healthy, Obesity, Pharmacokinetics
- Keywords
- Healthy, Obesity, Pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 22 participants
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Mar 2006
- Study completion
- Mar 2007 (actual)
- First posted
- 3 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valproic acid | Drug | – |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Ettinger, MD principal investigator
North Shore - Long Island Jewish Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valproic acid in people with Healthy and Obesity, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2012.