EpilepsyPhase 4NCT02404168
BEEP Follow Up: Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients
A Phase 4 study testing lamotrigine (brand Lamictal) and lamotrigine (generic Teva) in people with Epilepsy, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The prior BEEP study involved patients being switched between brand and generic in a very structured manner. Other secondary comparisons were also made (i.e. any differences in adverse effects and seizure control). Some subjects were more disparate than other, in terms of generic being similar to brand. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- lamotrigine (brand Lamictal) and lamotrigine (generic Teva)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2015to 6 Apr 2016
- 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 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is able to provide informed consent and was enrolled in previous BEEP study.
- Subject is male or female between 18 and 76 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 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 8 weeks prior to Visit 1 and during the screening period
- 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.
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- daily or weekly) use of acid blockers, antacids, anti-diarrhea, stimulants, appetite suppressants, or anti nausea medication or other drugs that modulate GI function
- 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
- 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 Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients
The prior BEEP study involved patients being switched between brand and generic in a very structured manner. Other secondary comparisons were also made (i.e. any differences in adverse effects and seizure control). Some subjects were more disparate than other, in terms of generic being similar to brand. In this follow up study, BEEP subjects that showed disparate results will be tested again to assess reproducibility of disparate results.
Read the detailed description
This is an double-blind, multiple-dose, full replicate design, pharmacokinetic study of lamotrigine in "enriched" patients with epilepsy who previously participated in HP-00048923. LAMICTAL 100mg tablets and the most commonly used generic lamotrigine 100mg tablet (from Teva) will be compared pharmacokinetically.
- Conditions
- Epilepsy
- Being tested
- lamotrigine (brand Lamictal), lamotrigine (generic Teva)
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lamotrigine (brand Lamictal)Drug
Also called Lamictal
an anti-epileptic drug (brand)
lamotrigine (generic Teva)Drug
Also called generic lamotrigine
an anti-epileptic drug (brand)
| Study group | Role | What they receive |
|---|---|---|
| lamotrigine brand tablet1 | Active comparator | lamotrigine tablet Lamictal Receives: Drug: lamotrigine (brand Lamictal) |
| lamotrigine generic tablet1 | Experimental | lamotrigine tablet Teva Receives: Drug: lamotrigine (generic Teva) |
| lamotrigine brand tablet2 | Active comparator | lamotrigine tablet Lamictal Receives: Drug: lamotrigine (brand Lamictal) |
| lamotrigine generic tablet2 | Experimental | lamotrigine tablet Teva Receives: Drug: lamotrigine (generic Teva) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
pharmacokinetic exposure (ng*hr/ml). Pharmacokinetic (PK) blood levels will be drawn at the schedule times: immediately prior to lamotrigine administration, then after drug administration at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, and 12.0 hr.
Measured: 0-12hr
Cmax
pharmacokinetic rate (ng/ml). Pharmacokinetic (PK) blood levels will be drawn at the schedule times: immediately prior to lamotrigine administration, then after drug administration at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, and 12.0 hr.
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 posted31 Mar 2015 (estimated)
- Study start7 Jul 2015
- Primary completion18 Jan 2016
- Study completion6 Apr 2016
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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James E Polli, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404168
- Sponsor's protocol ID
- HP-00063848
- Status last verified
- Aug 2019
- First submitted
- 17 Mar 2015
- Last updated
- 19 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients
- ClinicalTrials.gov ID
- NCT02404168
- Acronym / sponsor ID
- HP-00063848
- Conditions
- Epilepsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 7 Jul 2015 (actual)
- Primary completion
- 18 Jan 2016 (actual)
- Study completion
- 6 Apr 2016 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Posted 15 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prior BEEP study involved patients being switched between brand and generic in a very structured manner. Other secondary comparisons were also made (i.e. any differences in adverse effects and seizure control). Some subjects were more disparate than other, in terms of generic being similar to brand. In this follow up study, BEEP subjects that showed disparate results will be tested again to assess reproducibility of disparate results.
Detailed description
This is an double-blind, multiple-dose, full replicate design, pharmacokinetic study of lamotrigine in "enriched" patients with epilepsy who previously participated in HP-00048923. LAMICTAL 100mg tablets and the most commonly used generic lamotrigine 100mg tablet (from Teva) will be compared pharmacokinetically.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| lamotrigine brand tablet1 | Active comparator | Drug: lamotrigine (brand Lamictal)lamotrigine tablet Lamictal |
| lamotrigine generic tablet1 | Experimental | Drug: lamotrigine (generic Teva)lamotrigine tablet Teva |
| lamotrigine brand tablet2 | Active comparator | Drug: lamotrigine (brand Lamictal)lamotrigine tablet Lamictal |
| lamotrigine generic tablet2 | Experimental | Drug: lamotrigine (generic Teva)lamotrigine tablet Teva |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is able to provide informed consent and was enrolled in previous BEEP study.
- Subject is male or female between 18 and 76 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 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 8 weeks prior to Visit 1 and during the screening period
- Subject is willing to be switched between brand and generic lamotrigine
Key exclusion criteria (19 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 |
|---|---|---|
| lamotrigine (brand Lamictal)Also: Lamictalan anti-epileptic drug (brand) | Drug | lamotrigine brand tablet1, lamotrigine brand tablet2 |
| lamotrigine (generic Teva)Also: generic lamotriginean anti-epileptic drug (brand) | Drug | lamotrigine generic tablet1, lamotrigine generic tablet2 |
Primary outcome
AUC
Time frame: 0-12hr
pharmacokinetic exposure (ng*hr/ml). Pharmacokinetic (PK) blood levels will be drawn at the schedule times: immediately prior to lamotrigine administration, then after drug administration at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, and 12.0 hr.
Cmax
Time frame: 0-12hr
pharmacokinetic rate (ng/ml). Pharmacokinetic (PK) blood levels will be drawn at the schedule times: immediately prior to lamotrigine administration, then after drug administration at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, and 12.0 hr.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- 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 lamotrigine (brand Lamictal) and lamotrigine (generic Teva) 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 7 inclusion and 19 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 19 Aug 2019. 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 15 May 2019). 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 NCT02404168, 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 19 Aug 2019.