Last updated: 11/04/2018 08:50:53
Patients With Epilepsy Taking LAMICTAL Immediate-Release Who Switch To Extended-Release Formulation And Vice Versa
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: Pharmacokinetic (PK) study to characterize changes in serum concentrations in epilepsy patients when switching from LAMICTAL immediate-release to extended-release and vice versa.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
Not applicable
Allocation:
Non-randomized
Primary outcomes:
Steady state area under the curve from 0 to 24 hours (h) of lamotrigine (AUC 0-24) at indicated time points
Timeframe: Day 14, 15, 28 and 29
Maximum observed serum concentration (Cmax) of lamotrigine at indicated time points
Timeframe: Day 14, 15, 28 and 29
Pre-dose serum concentration (Ct [approximate Cmin]) of lamotrigine at indicated time points
Timeframe: Day 14, 15, 28 and 29
Secondary outcomes:
Time to maximum serum concentration (Tmax) of lamotrigine at indicated time points
Timeframe: Day 14, 15, 28, 29
Fluctuation index of lamotrigine at indicated time points
Timeframe: Day 14, 15, 28, 29
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Up to follow-up period (approximately 5 weeks)
Change from Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
Timeframe: Baseline (Screening, Visit 1, Day 0) and Visit 3 (Day 14 or 15), Visit 5 (Day 28 or 29) and Visit 6 (Day 35)
Change from Baseline in heart rate
Timeframe: Baseline (Screening, Visit 1, Day 0) and Visit 3 (Day 14 or 15), Visit 5 (Day 28 or 29) and Visit 6 (Day 35)
Change from Baseline in weekly seizure frequency during each of the study phases
Timeframe: Baseline (Screening, Visit 1, Day 0) and Visit 3 (Day 14 or 15), Visit 5 (Day 28 or 29) and Visit 6 (Day 35)
Investigator’s Assessment of Seizure Frequency during each of the study phases
Timeframe: Visit 3 (Day 14 or 15), Visit 5 (Day 28 or 29) and Visit 6 (Day 35)
Participant preference at End of Baseline and XR Treatment Phases
Timeframe: Visit 5 (Day 28 or 29) and Visit 6 (Day 35)
Interventions:
Drug: lamotrigine extended-release
Enrollment:
44
Observational study model:
Not applicable
Primary completion date:
2006-13-06
Time perspective:
Not applicable
Clinical publications:
D.J. Tompson, I. Ali, R. Oliver-Willwong, S. Job, L. Zhu, F. Lemme, A.E. Hammer, A. Vuong, J.A. Messenheimer 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;49;410-417
Medical condition
Epilepsy
Product
lamotrigine
Collaborators
Not applicable
Study date(s)
October 2005 to June 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
13+ years
Accepts healthy volunteers
No
- Confident diagnosis of epilepsy.
- Currently on LAMICTAL and up to 2 concomitant AEDs (anti-epileptic drugs).
- Females of childbearing potential cannot be on hormonal contraceptives or hormone replacement therapy.
Inclusion and exclusion criteria
Inclusion criteria:
- Confident diagnosis of epilepsy.
- Currently on LAMICTAL and up to 2 concomitant AEDs (anti-epileptic drugs).
Exclusion criteria:
- Females of childbearing potential cannot be on hormonal contraceptives or hormone replacement therapy.
Trial location(s)
Location
GSK Investigational Site
Richmond, Virginia, United States, 23219
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40536-0284
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37232
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02215
Status
Study Complete
Location
GSK Investigational Site
Anniston, Alabama, United States, 36207
Status
Study Complete
Location
GSK Investigational Site
Sun City, Arizona, United States, 85351
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Toledo, Ohio, United States, 43614-5809
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40503
Status
Study Complete
Location
GSK Investigational Site
Reno, Nevada, United States, 89521
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-13-06
Actual study completion date
2006-13-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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