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NCT02404168 · ClinicalTrials.gov registry record · Phase 4
BEEP Follow Up: Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients
A Phase 4 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
NCT02404168: Completed Phase 4 study, sponsored by University of Maryland, Baltimore.
NCT02404168 is a Phase 4 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 4 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02404168, a Phase 4 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
Study 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.
Primary Outcome
pharmacokinetic exposure (ng\*hr/ml). Pharmacokinetic (PK) blood levels will be drawn at the schedule times: immediately prior to lamotrigine administration, then after drug administration at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, and 12.0 hr.
Interventions
- DRUG lamotrigine (brand Lamictal)
- DRUG lamotrigine (generic Teva)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2015-07-07 |
| Est. Completion | 2016-04-06 |
| Phase | Phase 4 |
What the finished NCT02404168 record still lists
NCT02404168 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which lamotrigine (brand Lamictal) is the first listed.
NCT02404168 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02404168 about?
NCT02404168 is a clinical study titled "BEEP Follow Up: Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients". 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 br...
What is the current status of trial NCT02404168?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2015-07-07. Estimated completion is 2016-04-06.
What interventions are being tested in trial NCT02404168?
The interventions under investigation include: lamotrigine (brand Lamictal) (DRUG), lamotrigine (generic Teva) (DRUG).
Who is sponsoring clinical trial NCT02404168?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02404168's enrollment target sits among peer trials
4 1994th of 2000 higher than 6 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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