drugset / Trial / NCT02404168

BEEP Follow Up: Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients

NCT02404168

Phase 4 Completed 4 enrolled University of Maryland, Baltimore
Non-randomizedCrossoverTriple-blindBasic science

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. In this follow up study, BEEP subjects that showed disparate results will be tested again to assess reproducibility of disparate results.

Timeline

Start
2015-07-07
Primary completion
2016-01-18
Completion
2016-04-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Lamotrigine Small molecule 100 mg

Indications