EpilepsyPhase 3NCT00264615
Patients With Epilepsy Taking LAMICTAL Immediate-Release Who Switch To Extended-Release Formulation And Vice Versa
A Phase 3 study testing lamotrigine extended-release in people with Epilepsy, run by GlaxoSmithKline at 12 sites in United States.
Trial summary
Pharmacokinetic (PK) study to characterize changes in serum concentrations in epilepsy patients when switching from LAMICTAL immediate-release to extended-release and vice versa. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- lamotrigine extended-release
- How many people
- 45 participants
- Where
- 12 sitesUnited States
- Study dates
- Oct 2005to Jun 2006
- Phase
- Phase 3
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confident diagnosis of epilepsy.
- Currently on LAMICTAL and up to 2 concomitant AEDs (anti-epileptic drugs).
Who cannot join
- Females of childbearing potential cannot be on hormonal contraceptives or hormone replacement therapy.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
GSK Investigational Site
Anniston, Alabama, 36207
GSK Investigational Site
Boston, Massachusetts, 02215
GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
Lexington, Kentucky, 40503
GSK Investigational Site
Lexington, Kentucky, 40536-0284
GSK Investigational Site
Nashville, Tennessee, 37232
GSK Investigational Site
New York, New York, 10016
GSK Investigational Site
Philadelphia, Pennsylvania, 19140
GSK Investigational Site
Reno, Nevada, 89521
GSK Investigational Site
Richmond, Virginia, 23219
GSK Investigational Site
Sun City, Arizona, 85351
GSK Investigational Site
Toledo, Ohio, 43614-5809
About this study
Official title: An Open-label, Double Conversion Study to Characterize the Pharmacokinetics of Lamotrigine When Switching Patients With Epilepsy on LAMICTAL Immediate-release to Extended-release Formulation and Vice Versa
Pharmacokinetic (PK) study to characterize changes in serum concentrations in epilepsy patients when switching from LAMICTAL immediate-release to extended-release and vice versa.
- Conditions
- Epilepsy
- Being tested
- lamotrigine extended-release
- Keywords
- once daily dosing, seizure, pharmacokinetics, epilepsy
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lamotrigine extended-releaseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady state AUC(0-24), Cmax and Ct (approximate Cmin) of lamotrigine
Secondary outcomes (4)
Tmax and fluctuation index of lamotrigine
Adverse events, changes in blood pressure and heart rate
Change in seizure frequency during each of the study phases
Subject preference at End of Baseline and Extended-Release Treatment Phases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
- Study startOct 2005
- Primary completionJun 2006
- Study completionJun 2006
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 GlaxoSmithKlineThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264615
- Sponsor's protocol ID
- LEP103944
- Status last verified
- Sep 2016
- First submitted
- 9 Dec 2005
- Last updated
- 23 Sep 2016
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Tompson DJ, Ali I, Oliver-Willwong R, Job S, Zhu L, Lemme F, Hammer AE, Vuong A, Messenheimer JA. Steady-state pharmacokinetics of lamotrigine when converting from a twice-daily immediate-release to a once-daily extended-release formulation in subjects with epilepsy (The COMPASS Study). Epilepsia. 2008 Mar;49(3):410-7. doi: 10.1111/j.1528-1167.2007.01274.x. Epub 2007 Sep 6.
PubMed 17825077van Dijkman SC, de Jager NCB, Rauwe WM, Danhof M, Della Pasqua O. Effect of Age-Related Factors on the Pharmacokinetics of Lamotrigine and Potential Implications for Maintenance Dose Optimisation in Future Clinical Trials. Clin Pharmacokinet. 2018 Aug;57(8):1039-1053. doi: 10.1007/s40262-017-0614-5.
PubMed 29363050
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Double Conversion Study to Characterize the Pharmacokinetics of Lamotrigine When Switching Patients With Epilepsy on LAMICTAL Immediate-release to Extended-release Formulation and Vice Versa
- ClinicalTrials.gov ID
- NCT00264615
- Acronym / sponsor ID
- LEP103944
- Conditions
- Epilepsy
- Keywords
- once daily dosing, seizure, pharmacokinetics, epilepsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 13 Dec 2005 (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.
Pharmacokinetic (PK) study to characterize changes in serum concentrations in epilepsy patients when switching from LAMICTAL immediate-release to extended-release and vice versa.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Confident diagnosis of epilepsy.
- Currently on LAMICTAL and up to 2 concomitant AEDs (anti-epileptic drugs).
Key exclusion criteria (1 listed)
- Females of childbearing potential cannot be on hormonal contraceptives or hormone replacement therapy.
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 extended-release | Drug | – |
Primary outcome
Steady state AUC(0-24), Cmax and Ct (approximate Cmin) of lamotrigine
4 secondary outcomes
Tmax and fluctuation index of lamotrigine
Adverse events, changes in blood pressure and heart rate
Change in seizure frequency during each of the study phases
Subject preference at End of Baseline and Extended-Release Treatment Phases
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 23 Sep 2016.
- Background: PubMed 17825077Tompson DJ, Ali I, Oliver-Willwong R, Job S, Zhu L, Lemme F, Hammer AE, Vuong A, Messenheimer JA. Steady-state pharmacokinetics of lamotrigine when converting from a twice-daily immediate-release to a once-daily extended-release formulation in subjects with epilepsy (The COMPASS Study). Epilepsia. 2008 Mar;49(3):410-7. doi: 10.1111/j.1528-1167.2007.01274.x. Epub 2007 Sep 6.
- Derived from this study: PubMed 29363050van Dijkman SC, de Jager NCB, Rauwe WM, Danhof M, Della Pasqua O. Effect of Age-Related Factors on the Pharmacokinetics of Lamotrigine and Potential Implications for Maintenance Dose Optimisation in Future Clinical Trials. Clin Pharmacokinet. 2018 Aug;57(8):1039-1053. doi: 10.1007/s40262-017-0614-5.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lamotrigine extended-release in people with Epilepsy, run by GlaxoSmithKline at 12 sites 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 2 inclusion and 1 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 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Steady state AUC(0-24), Cmax and Ct (approximate Cmin) of lamotrigine. 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 NCT00264615, 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 23 Sep 2016.