A Study in Stable Epilepsy Patients Comparing Brand and Generic Divalproex Sodium Extended Release Tablets (Epilepsy)

July 9, 2013 updated by: Vince & Associates Clinical Research, Inc.

An Open Label, Randomized, Four-period, Two-sequence, Fully Replicated, Single-dose, Crossover Study of the Relative Bioavailability of Two Formulations of Extended-release Divalproex Sodium Tablets in Fed Patients With Stable Epilepsy.

A study in stable epilepsy patients comparing levels of valproic acid after administration of brand and generic divalproex sodium extended release tablets.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study consists of a screening visit, four treatment periods and a final follow-up visit. Each treatment period consists of a four night in-house stay followed by two outpatient visits. Each treatment period will be separated by a washout period. During each treatment period, safety evaluations will include vital signs, physical exams, safety laboratory tests, weight measurement, electrocardiograms, adverse event collection and concomitant medication recording. Pharmacokinetic blood samples will be collected during each treatment period. Seizure activity will be recorded in a seizure diary during the study. A standardized high-fat, high-calorie meal will be served prior to each dose during each treatment period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Recruiting
        • Vince & Associates Clinical Research, Inc.
        • Contact:
        • Principal Investigator:
          • Bradley D Vince, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to understand, sign and date the informed consent form
  • Male or female 18 to 55 years old with a diagnosis of epilepsy who are stable
  • Body mass 18 to 34 kg/m, inclusive
  • Is continuously receiving a fixed dose of their AED medication(s)for a minimum of 30 days prior to screening
  • Stay on the same dosages of their routine concomitant medications throughout the study
  • Healthy, as determined by pre-study medical history, vital signs, physical exam, ECG and the opinion of the investigator
  • Normal renal function per laboratory test
  • No clinically relevant labs.
  • Negative for hepatitis B, C and HIV
  • For females, negative pregnancy test
  • Negative for drugs of abuse and alcohol
  • Nonsmoker or has not smoked within the past six months.
  • Some over-the-counter medications may be permitted at the discretion of the investigator
  • Able to communicate well and comply with study procedures, requirements and restrictions

Exclusion Criteria:

  • History or presence of clinically significant medical disorders
  • Have a current psychiatric disorder
  • History of status epilepticus within 90 days of screening
  • Any other condition that the investigator would feel could interfere with the safety of the subject or the study protocol.
  • Taking three or more AED medications
  • Use of felbamate, aspirin, carbapenem antibiotics, rifampin, ritonavir, macrolide antibiotics, cholestyramine, and/or risperidone.
  • Use of any investigational agent or medical device within 30 days of screening.
  • History of clinically significant drug allergy that in the opinion of the investigator may compromise the subject's safety or study results.
  • History of known hypersensitivity to divalproex sodium or its excipients
  • History of alcohol or drug abuse or dependence in the past 5 years
  • Consumed alcohol, caffeine or other xanthine-containing foods or beverages within 48 hours prior to each clinic admission.
  • Consumed grapefruit and/or grapefruit containing products within days prior to admission to the clinic on Day -1 and they agree not to consume grapefruit and/or grapefruit containing products for the duration of their study involvement
  • Participated in any strenuous physical exercise within 72 hours before admission to the clinic on Day 1 and agrees to abstain from the duration of their study involvement.
  • Acute illness at screening and/or at admission to the clinic
  • Lactose intolerance or unusual dietary habits.
  • Blood donation within 8 weeks of admission to this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Divalproex Sodium Extended Release 250mg
Treatment A: A single 2-tablet dose of divalproex sodium extended-release tablet, 250mg. Each subject will have 2 treatments with this medication and two treatments with a single 2-tablet dose of DEPAKOTE 250mg tablet.
Drug: Divalproex Sodium Extended-release 250mg
Two tablets of Divalproex Sodium Extended-Release 250mg will be given to the subject in two treatment periods
Other Names:
  • DEPAKOTE 250mg
Drug: DEPAKOTE 250mg
Two tablets of DEPAKOTE 250mg will be given to the subject in two treatment periods.
Other Names:
  • Divalproex Sodium Extended-Release 250mg
Active Comparator: DEPAKOTE 250mg
Treatment B: A single 2-tablet dose of DEPAKOTE ER tablet, 250mg. Each subject will have 2 treament period with this medication and 2 treatment periods with a single 2-tablet dose of Divalproex Sodium Extended-Release 250mg tablet.
Drug: Divalproex Sodium Extended-release 250mg
Two tablets of Divalproex Sodium Extended-Release 250mg will be given to the subject in two treatment periods
Other Names:
  • DEPAKOTE 250mg
Drug: DEPAKOTE 250mg
Two tablets of DEPAKOTE 250mg will be given to the subject in two treatment periods.
Other Names:
  • Divalproex Sodium Extended-Release 250mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Evaluate generic divalproex sodium extended release to Depakote ER
Time Frame: Approximately 2.5 months
This is an open-label, randomized, two-sequence, two-treatment, single dose, four-period, fully replicated crossover study in which 16 subjects will receive one of the two study drugs, Depakote ER or a generic equivalent, during each treatment period. Subjects will be patients with epilepsy who are otherwise healthy and who are stable on anti-epileptic therapy, not including any formulation of divalproex sodium.
Approximately 2.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vince & Associates Clinical Research, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Food and Drug Administration (FDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bradley D. Vince, DO, Vince & Associates Clinical Research, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RIHSC #13-019D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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