NCT02404168

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

Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	lamotrigine (brand Lamictal)	an anti-epileptic drug (brand)
DRUG	lamotrigine (generic Teva)	an anti-epileptic drug (brand)

Timeline

• Start date: 2015-07-07
• Primary completion: 2016-01-18
• Completion: 2016-04-06
• First posted: 2015-03-31
• Last updated: 2019-08-19
• Results posted: 2019-05-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study