EpilepsyPhase 4NCT01995825
Lamotrigine Bioequivalence
A Phase 4 study testing Brand lamotrigine and Generic lamotrigine in people with Epilepsy, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
In this study, brand name lamotrigine (LAMICTAL) and generic lamotrigine will be compared in patients with epilepsy. Both the brand name and generic lamotrigine are approved by the Food and Drug Administration (FDA) and are commonly used to treat epilepsy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- Brand lamotrigine and Generic lamotrigine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Oct 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject is able to provide informed consent.
- Subject is male or female between 18 and 65 years of age inclusive.
- Subject has a diagnosis of epilepsy with simple partial seizures and/or complex partial seizures, with or without secondary generalization or primary generalized seizures.
- Subject has had a history of at least one seizure and/or AED related adverse event with AED changes; or had at least one seizure and/or AED related adverse event over the 12 months prior to Visit 1.
- Subject has been maintained on a stable dose regimen of anti-epileptic drugs (AEDs), including lamotrigine at 200mg, 400mg, or 600mg total daily dosage divided BID for at least 28 days prior to Visit 1. Additionally, subject must be taking lamotrigine for 8 weeks prior to Visit 1.
- Subject is willing to be switched between brand and generic lamotrigine.
- Subject is an acceptable candidate for venipuncture.
- Subject is willing to stop all OTC medications for 24 hours prior to and during 12 hour study visits.
Who cannot join
- Subject is currently participating or has participated within the last 2 months in any trial of an investigational drug or experimental device.
- Subject has a history of status epilepticus within the 12 month period prior to Visit 1.
- Subject has any medical condition, which in the opinion of the investigator, could jeopardize the subject's health or would compromise the subject's ability to participate in the trial.
- Subject has any psychiatric condition, which in the opinion of the investigator, could jeopardize the subject's health or would compromise the subject's ability to participate in this trial or confound the interpretation of the trial data.
- Subject has known hypersensitivity to lamotrigine.
- Subject has a medical condition that impacts drug absorption (e.g. gastric bypass surgery), including routine use (i.e. daily or weekly) use of acid blockers, antacids, anti-diarrhea, stimulants, appetite suppressants, or anti nausea medication or other drugs that modulate GI function.
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- Subject has any history of alcohol or drug abuse within the previous two years.
- Subject has acute or subacutely progressive CNS disease.
- Subject has moderate or severe liver impairment as assessed by alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels ≥5 times the upper limit of normal (ULN).
- Subject has moderate or severe renal impairment as assessed by creatinine clearance lower than 50mL/min, using the Cockcroft-Gault formula.
- Female subjects of childbearing potential will not be eligible to participate who are unwilling or unable to use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: condom with spermicide, diaphragm with spermicide, IUD without progesterone, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence.
- Female subject is pregnant or nursing.
- Female subject is using hormonal contraceptive precautions including progesterone-coated IUD.
- Subjects is using hormonal replacement therapy.
- Subject is unwilling or unable to maintain their approximate daily smoking use during the study.
- Subject is using rifampin or other non-AED that strongly modulates lamotrigine levels.
- In addition to lamotrigine and/or vagus nerve stimulation and/or intermittent benzodiazepine use (e.g. lorazepam, diazepam, clonazepam), subject is taking more than two concomitant AEDs.
- Subject is not willing or able to be adherent to study protocol (e.g. dosing of lamotrigine and any interacting comedication).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Bioequivalence of Lamotrigine Tablets in Epileptic Patients
In this study, brand name lamotrigine (LAMICTAL) and generic lamotrigine will be compared in patients with epilepsy. Both the brand name and generic lamotrigine are approved by the Food and Drug Administration (FDA) and are commonly used to treat epilepsy. Some physicians and patients with epilepsy have believed that brand and generic lamotrigine have had clinically significant differences in efficacy and tolerability. The brand name and generic tablets have been shown to be the same when blood levels were measured in healthy volunteers without epilepsy, but these drugs have not yet been compared in patients with epilepsy. This study will do this comparison, by switching patients between brand and generic in a very structured manner, and seeing if the drugs are the same, primarily in terms of blood levels. Other comparisons will also be made secondarily, looking for any differences in adverse effects and seizure control.
Read the detailed description
As is commonly done in a bioequivalence study, the null hypothesis is that the generic (i.e. test) is bioINequivalent to the brand name (i.e. reference). Hence, the alternative hypothesis is that the generic is bioequivalent to the brand name.
- Conditions
- Epilepsy
- Being tested
- Brand lamotrigine, Generic lamotrigine
- Keywords
- bioequivalence, lamotrigine, epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brand lamotrigineDrug
Brand lamotrigine tablet 100mg tablets (1-3 either once or twice a day) for two weeks
Generic lamotrigineDrug
Generic lamotrigine tablet 100mg tablets (1-3 either once or twice a day) for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Brand lamotrigine then Generic lamotrigine | Experimental | Crossover trial. Each arm will receive Brand lamotrigine tablet for two periods and Generic lamotrigine for two periods. Receives: Drug: Brand lamotrigine; Drug: Generic lamotrigine |
| Generic lamotrigine then Brand lamotrigine | Experimental | Crossover trial. Each arm will receive Generic lamotrigine tablet for two periods and Brand lamotrigine for two periods. Receives: Drug: Brand lamotrigine; Drug: Generic lamotrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
pharmacokinetic exposure (ng*hr/ml)
Measured: 0-12hr
Cmax
highest concentration over the time duration 0-12hr (ng/ml)
Measured: 0-12hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startMay 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, James E Polli, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995825
- Sponsor's protocol ID
- HP-00048923
- Other IDs
- HHSF223201010144A
- Status last verified
- Nov 2020
- First submitted
- 26 Jan 2013
- Last updated
- 1 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Andermann F, Duh MS, Gosselin A, Paradis PE. Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes. Epilepsia. 2007 Mar;48(3):464-9. doi: 10.1111/j.1528-1167.2007.01007.x.
PubMed 17346246
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Bioequivalence of Lamotrigine Tablets in Epileptic Patients
- ClinicalTrials.gov ID
- NCT01995825
- Acronym / sponsor ID
- HP-00048923
- Conditions
- Epilepsy
- Keywords
- bioequivalence, lamotrigine, epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- May 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Posted 1 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, brand name lamotrigine (LAMICTAL) and generic lamotrigine will be compared in patients with epilepsy. Both the brand name and generic lamotrigine are approved by the Food and Drug Administration (FDA) and are commonly used to treat epilepsy. Some physicians and patients with epilepsy have believed that brand and generic lamotrigine have had clinically significant differences in efficacy and tolerability. The brand name and generic tablets have been shown to be the same when blood levels were measured in healthy volunteers without epilepsy, but these drugs have not yet been compared in patients with epilepsy. This study will do this comparison, by switching patients between brand and generic in a very structured manner, and seeing if the drugs are the same, primarily in terms of blood levels. Other comparisons will also be made secondarily, looking for any differences in adverse effects and seizure control.
Detailed description
As is commonly done in a bioequivalence study, the null hypothesis is that the generic (i.e. test) is bioINequivalent to the brand name (i.e. reference). Hence, the alternative hypothesis is that the generic is bioequivalent to the brand name.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brand lamotrigine then Generic lamotrigine | Experimental | Drug: Brand lamotrigine, Drug: Generic lamotrigineCrossover trial. Each arm will receive Brand lamotrigine tablet for two periods and Generic lamotrigine for two periods. |
| Generic lamotrigine then Brand lamotrigine | Experimental | Drug: Brand lamotrigine, Drug: Generic lamotrigineCrossover trial. Each arm will receive Generic lamotrigine tablet for two periods and Brand lamotrigine for two periods. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is able to provide informed consent.
- Subject is male or female between 18 and 65 years of age inclusive.
- Subject has a diagnosis of epilepsy with simple partial seizures and/or complex partial seizures, with or without secondary generalization or primary generalized seizures.
- Subject has had a history of at least one seizure and/or AED related adverse event with AED changes; or had at least one seizure and/or AED related adverse event over the 12 months prior to Visit 1.
- Subject has been maintained on a stable dose regimen of anti-epileptic drugs (AEDs), including lamotrigine at 200mg, 400mg, or 600mg total daily dosage divided BID for at least 28 days prior to Visit 1. Additionally, subject must be taking lamotrigine for 8 weeks prior to Visit 1.
Key exclusion criteria (18 listed)
- Subject is currently participating or has participated within the last 2 months in any trial of an investigational drug or experimental device.
- Subject has a history of status epilepticus within the 12 month period prior to Visit 1.
- Subject has any medical condition, which in the opinion of the investigator, could jeopardize the subject's health or would compromise the subject's ability to participate in the trial.
- Subject has any psychiatric condition, which in the opinion of the investigator, could jeopardize the subject's health or would compromise the subject's ability to participate in this trial or confound the interpretation of the trial data.
- Subject has known hypersensitivity to lamotrigine.
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 |
|---|---|---|
| Brand lamotrigineBrand lamotrigine tablet 100mg tablets (1-3 either once or twice a day) for two weeks | Drug | Brand lamotrigine then Generic lamotrigine, Generic lamotrigine then Brand lamotrigine |
| Generic lamotrigineGeneric lamotrigine tablet 100mg tablets (1-3 either once or twice a day) for two weeks | Drug | Brand lamotrigine then Generic lamotrigine, Generic lamotrigine then Brand lamotrigine |
Primary outcome
AUC
Time frame: 0-12hr
pharmacokinetic exposure (ng*hr/ml)
Cmax
Time frame: 0-12hr
highest concentration over the time duration 0-12hr (ng/ml)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17346246Andermann F, Duh MS, Gosselin A, Paradis PE. Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes. Epilepsia. 2007 Mar;48(3):464-9. doi: 10.1111/j.1528-1167.2007.01007.x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Brand lamotrigine and Generic lamotrigine in people with Epilepsy, run by University of Maryland, Baltimore 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 8 inclusion and 18 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 1 Dec 2020. 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?
Yes. Results are posted in the registry (first posted 1 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
AUC (time frame: 0-12hr). The study lists 2 primary outcomes in all. 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 NCT01995825, which also lists 1 linked publication.
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 1 Dec 2020.