EpilepsyPhase 1EpilepsyNCT01898676
A Study in Stable Epilepsy Patients Comparing Brand and Generic Divalproex Sodium Extended Release Tablets
A Phase 1 study testing Divalproex Sodium Extended-release 250mg and DEPAKOTE 250mg in people with Epilepsy, run by Vince & Associates Clinical Research, Inc. at 1 site in United States.
Trial summary
A study in stable epilepsy patients comparing levels of valproic acid after administration of brand and generic divalproex sodium extended release tablets. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Divalproex Sodium Extended-release 250mg and DEPAKOTE 250mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2013
- Phase
- Phase 1
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Vince & Associates Clinical Research, Inc.
Overland Park, Kansas, 66212
David Wood, 913-696-1601, dwood@vinceandassociates.com
Bradley D Vince, DO
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Divalproex Sodium Extended-release 250mg, DEPAKOTE 250mg
- Keywords
- Extended-release divalproex sodium, Depakote ER
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Divalproex Sodium Extended-release 250mgDrug
Also called DEPAKOTE 250mg
Two tablets of Divalproex Sodium Extended-Release 250mg will be given to the subject in two treatment periods
DEPAKOTE 250mgDrug
Also called Divalproex Sodium Extended-Release 250mg
Two tablets of DEPAKOTE 250mg will be given to the subject in two treatment periods.
| Study group | Role | What they receive |
|---|---|---|
| Divalproex Sodium Extended Release 250mg | Active comparator | 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. Receives: Drug: Divalproex Sodium Extended-release 250mg; Drug: DEPAKOTE 250mg |
| DEPAKOTE 250mg | Active comparator | 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. Receives: Drug: Divalproex Sodium Extended-release 250mg; Drug: DEPAKOTE 250mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate generic divalproex sodium extended release to Depakote ER
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.
Measured: Approximately 2.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vince & Associates Clinical Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Sponsor
- Investigators
- Bradley D. Vince, DO, Principal investigator, Vince & Associates Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898676
- Sponsor's protocol ID
- RIHSC #13-019D
- Acronym
- Epilepsy
- Status last verified
- Jun 2013
- First submitted
- 17 Jun 2013
- Last updated
- 12 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01898676
- Acronym / sponsor ID
- Epilepsy / RIHSC #13-019D
- Conditions
- Epilepsy
- Keywords
- Extended-release divalproex sodium, Depakote ER
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Vince & Associates Clinical Research, Inc.University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- Jul 2013
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 12 Jul 2013 (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.
A study in stable epilepsy patients comparing levels of valproic acid after administration of brand and generic divalproex sodium extended release tablets.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Divalproex Sodium Extended Release 250mg | Active comparator | Drug: Divalproex Sodium Extended-release 250mg, Drug: DEPAKOTE 250mgTreatment 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. |
| DEPAKOTE 250mg | Active comparator | Drug: Divalproex Sodium Extended-release 250mg, Drug: DEPAKOTE 250mgTreatment 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| Divalproex Sodium Extended-release 250mgAlso: DEPAKOTE 250mgTwo tablets of Divalproex Sodium Extended-Release 250mg will be given to the subject in two treatment periods | Drug | DEPAKOTE 250mg, Divalproex Sodium Extended Release 250mg |
| DEPAKOTE 250mgAlso: Divalproex Sodium Extended-Release 250mgTwo tablets of DEPAKOTE 250mg will be given to the subject in two treatment periods. | Drug | DEPAKOTE 250mg, Divalproex Sodium Extended Release 250mg |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2013.
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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.
Vince & Associates Clinical Research, Inc.
Overland Park, United States
Bradley D. Vince, DO principal investigator
Vince & Associates Clinical Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Divalproex Sodium Extended-release 250mg and DEPAKOTE 250mg in people with Epilepsy, run by Vince & Associates Clinical Research, Inc. 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 14 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 12 Jul 2013. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate generic divalproex sodium extended release to Depakote ER (time frame: Approximately 2.5 months). 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 12 Jul 2013.