EpilepsyNCT02113787
Switchability Study Between Brand and Generic Topiramate
A study testing Pharmacokinetic study in people with Epilepsy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of the study is to prove the bioequivalence of brand and generic topiramate. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Pharmacokinetic study
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to May 2017
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-65 years
- Patients with epilepsy who take by topamax 100mg bid or who need to take topamax 100mg bid
Who cannot join
- poor compliance
- subjects whose dose of antiepileptic drug are changed during the study
- subjects whose seizure is not well-controlled judged by neurologist
- history of any kind of drug allergy
- pregnancy or nursing
- existing or recent significant disease (cardiac, hepatic, or renal disease, severe diabetes mellitus, sepsis, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Pharmacokinetics Comparing Brand and Generic Topiramate in Epilepsy Patients : A Open-label,Randomised, Three-period Crossover Study
The purpose of the study is to prove the bioequivalence of brand and generic topiramate.
Read the detailed description
Generic antiepileptic drugs (AED) achieve blood concentration similar to the brand AED. However, controversies exist about efficacy and safety of substituting generic AEDs. Because even minor absorption and kinetic differences can elicit a breakthrough seizure in patients who are changed to a generic AED from brand AED. Therefore, more ideal evaluation of interchangeability from the brand AEDs to generic formulation of the same drug is three-way or four-way crossover study, which can evaluate within-subject variability in pharmacokinetic and pharmacodynamic. Investigator designed four-way crossover study aimed to assess bioequivalence of brand and generic topiramate, to measure trough serum level , and to evaluate efficacy, tolerability and side effect of generic topiramate.
- Conditions
- Epilepsy
- Being tested
- Pharmacokinetic study
- Keywords
- epilepsy, anticonvulsants, generic drugs
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacokinetic studyProcedure or surgery
Patients who are examen pharmacokinetic study after taking Topamax or Topiramate during 7 days
| Study group | Role | What they receive |
|---|---|---|
| Pharmacokinetic study, topamed | Active comparator | For pharmacokinetics, blood samples was taken after receiving Topamax 100mg twice a day in first visit day.
For pharmacokinetics, blood samples was taken after receiving Topamed 100mg twice a day in second visit day.
For pharmacokinetics, blood samples was taken after receiving Topamax 100mg twice a day in third visit day.
For pharmacokinetics, blood samples was taken after receiving Topamed 100mg twice a day in third visit day. Receives: Procedure: Pharmacokinetic study |
| Pharmacokinetic study, topamax | Active comparator | For pharmacokinetics, blood samples was taken after receiving Topamed 100mg twice a day in first visit day.
For pharmacokinetics, blood samples was taken after receiving Topamax 100mg twice a day in second visit day.
For pharmacokinetics, blood samples was taken after receiving Topamed 100mg twice a day in third visit day.
For pharmacokinetics, blood samples was taken after receiving Topamax 100mg twice a day in third visit day. Receives: Procedure: Pharmacokinetic study |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Measure the Area under the plasma concentration versus time curve, serum trough drug level of generic and brand topiramate through pharmacokinetics study.
All comparisons of the drug formulations fulfill the bioequivalence criteria, with all 90% Confidential intervals(CIs) for Cmax, AUC, and Ctrough being within the 80-125% acceptance range.
Scaling average bioequivalence that the acceptable bioequivalence limits of 90% CI of generic to brand topiramate will be those limits that are within and/or similar to the bioequivalence limits of the 90% CI of Brand to Brand topiramate
Measured: [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after taking the brand or generic topiramate during 7 days]
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of generic topiramate in subjects with epilepsy
Measured: 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kon Chu, Seoul National University Hospital
- Investigators
- Kon Chu, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113787
- Sponsor's protocol ID
- 0620140190 (2013-2172)
- Status last verified
- Sep 2021
- First submitted
- 19 Mar 2014
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Bialer M, Midha KK. Generic products of antiepileptic drugs: a perspective on bioequivalence and interchangeability. Epilepsia. 2010 Jun;51(6):941-50. doi: 10.1111/j.1528-1167.2010.02573.x. Epub 2010 Apr 8.
PubMed 20384761Erickson SC, Le L, Ramsey SD, Solow BK, Zakharyan A, Stockl KM, Harada AS, Curtis B. Clinical and pharmacy utilization outcomes with brand to generic antiepileptic switches in patients with epilepsy. Epilepsia. 2011 Jul;52(7):1365-71. doi: 10.1111/j.1528-1167.2011.03130.x. Epub 2011 Jun 21.
PubMed 21692778
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Pharmacokinetics Comparing Brand and Generic Topiramate in Epilepsy Patients : A Open-label,Randomised, Three-period Crossover Study
- ClinicalTrials.gov ID
- NCT02113787
- Acronym / sponsor ID
- 0620140190 (2013-2172)
- Conditions
- Epilepsy
- Keywords
- epilepsy, anticonvulsants, generic drugs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 15 Apr 2014 (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 the study is to prove the bioequivalence of brand and generic topiramate.
Detailed description
Generic antiepileptic drugs (AED) achieve blood concentration similar to the brand AED. However, controversies exist about efficacy and safety of substituting generic AEDs. Because even minor absorption and kinetic differences can elicit a breakthrough seizure in patients who are changed to a generic AED from brand AED. Therefore, more ideal evaluation of interchangeability from the brand AEDs to generic formulation of the same drug is three-way or four-way crossover study, which can evaluate within-subject variability in pharmacokinetic and pharmacodynamic. Investigator designed four-way crossover study aimed to assess bioequivalence of brand and generic topiramate, to measure trough serum level , and to evaluate efficacy, tolerability and side effect of generic topiramate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacokinetic study, topamed | Active comparator | Procedure: Pharmacokinetic studyFor pharmacokinetics, blood samples was taken after receiving Topamax 100mg twice a day in first visit day. For pharmacokinetics, blood samples was taken after receiving Topamed 100mg twice a day in second visit day. For pharmacokinetics, blood samples was taken after receiving Topamax 100mg twice a day in third visit day. For pharmacokinetics, blood samples was taken after receiving Topamed 100mg twice a day in third visit day. |
| Pharmacokinetic study, topamax | Active comparator | Procedure: Pharmacokinetic studyFor pharmacokinetics, blood samples was taken after receiving Topamed 100mg twice a day in first visit day. For pharmacokinetics, blood samples was taken after receiving Topamax 100mg twice a day in second visit day. For pharmacokinetics, blood samples was taken after receiving Topamed 100mg twice a day in third visit day. For pharmacokinetics, blood samples was taken after receiving Topamax 100mg twice a day in third visit day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 18-65 years
- Patients with epilepsy who take by topamax 100mg bid or who need to take topamax 100mg bid
Key exclusion criteria (6 listed)
- poor compliance
- subjects whose dose of antiepileptic drug are changed during the study
- subjects whose seizure is not well-controlled judged by neurologist
- history of any kind of drug allergy
- pregnancy or nursing
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 |
|---|---|---|
| Pharmacokinetic studyPatients who are examen pharmacokinetic study after taking Topamax or Topiramate during 7 days | Procedure or surgery | Pharmacokinetic study, topamax, Pharmacokinetic study, topamed |
Primary outcome
To Measure the Area under the plasma concentration versus time curve, serum trough drug level of generic and brand topiramate through pharmacokinetics study.
Time frame: [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after taking the brand or generic topiramate during 7 days]
All comparisons of the drug formulations fulfill the bioequivalence criteria, with all 90% Confidential intervals(CIs) for Cmax, AUC, and Ctrough being within the 80-125% acceptance range. Scaling average bioequivalence that the acceptable bioequivalence limits of 90% CI of generic to brand topiramate will be those limits that are within and/or similar to the bioequivalence limits of the 90% CI of Brand to Brand topiramate
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability of generic topiramate in subjects with epilepsy
Time frame: 4weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Background: PubMed 20384761Bialer M, Midha KK. Generic products of antiepileptic drugs: a perspective on bioequivalence and interchangeability. Epilepsia. 2010 Jun;51(6):941-50. doi: 10.1111/j.1528-1167.2010.02573.x. Epub 2010 Apr 8.
- Background: PubMed 21692778Erickson SC, Le L, Ramsey SD, Solow BK, Zakharyan A, Stockl KM, Harada AS, Curtis B. Clinical and pharmacy utilization outcomes with brand to generic antiepileptic switches in patients with epilepsy. Epilepsia. 2011 Jul;52(7):1365-71. doi: 10.1111/j.1528-1167.2011.03130.x. Epub 2011 Jun 21.
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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.
Kon Chu, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacokinetic study in people with Epilepsy, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 29 Sep 2021. 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 South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To Measure the Area under the plasma concentration versus time curve, serum trough drug level of generic and brand topiramate through pharmacokinetics study. (time frame: [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours after taking the brand or generic topiramate during 7 days]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02113787, which also lists 2 linked publications.
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 29 Sep 2021.