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Pharmacokinetic (PK) study to characterize changes in serum concentrations in epilepsy patients when switching from LAMICTAL immediate-release to extended-release and vice versa.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lamotrigine extended-release | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Steady state AUC(0-24), Cmax and Ct (approximate Cmin) of lamotrigine |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Anniston | Alabama | 36207 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17825077 | Background | 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. | |
| 29363050 |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| LEP103944 | Annotated Case Report Form | View IPD |
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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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 19, 2017 | |
| Unrelease | Yes | |
| Release | Jun 23, 2017 |
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| Subject preference at End of Baseline and Extended-Release Treatment Phases |
| Sun City |
| Arizona |
| 85351 |
| United States |
| GSK Investigational Site | Lexington | Kentucky | 40503 | United States |
| GSK Investigational Site | Lexington | Kentucky | 40536-0284 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02215 | United States |
| GSK Investigational Site | Reno | Nevada | 89521 | United States |
| GSK Investigational Site | New York | New York | 10016 | United States |
| GSK Investigational Site | Toledo | Ohio | 43614-5809 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19140 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37232 | United States |
| GSK Investigational Site | Dallas | Texas | 75230 | United States |
| GSK Investigational Site | Richmond | Virginia | 23219 | United States |
| Derived |
| van 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. |
For additional information about this study please refer to the GSK Clinical Study Register |
| LEP103944 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LEP103944 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LEP103944 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LEP103944 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LEP103944 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| LEP103944 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Reset | Nov 22, 2017 |
| Release | Nov 30, 2017 |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 19, 2017 | Yes | |||
| Jun 23, 2017 | Nov 22, 2017 | |||
| Nov 30, 2017 | Aug 15, 2018 |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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