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NCT01995825 · ClinicalTrials.gov registry record · Phase 4
Lamotrigine Bioequivalence
A Phase 4 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 4
- Development phase
- 35
- Enrollment target
NCT01995825: Completed Phase 4 study, sponsored by University of Maryland, Baltimore.
NCT01995825 is a Phase 4 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 35 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01995825, a Phase 4 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 35 participants
- Enrollment target
Study Summary
In this study, brand name lamotrigine (LAMICTAL) and generic lamotrigine will be compared in patients with epilepsy. Both the brand name and generic lamotrigine are approved by the Food and Drug Administration (FDA) and are commonly used to treat epilepsy. Some physicians and patients with epilepsy have believed that brand and generic lamotrigine have had clinically significant differences in efficacy and tolerability. The brand name and generic tablets have been shown to be the same when blood levels were measured in healthy volunteers without epilepsy, but these drugs have not yet been compared in patients with epilepsy. This study will do this comparison, by switching patients between brand and generic in a very structured manner, and seeing if the drugs are the same, primarily in terms of blood levels. Other comparisons will also be made secondarily, looking for any differences in adverse effects and seizure control.
Primary Outcome
pharmacokinetic exposure (ng\*hr/ml)
Interventions
- DRUG Brand lamotrigine
- DRUG Generic lamotrigine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2012-05 |
| Est. Completion | 2013-10 |
| Phase | Phase 4 |
What the finished NCT01995825 record still lists
NCT01995825 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Brand lamotrigine is the first listed.
NCT01995825 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01995825 about?
NCT01995825 is a clinical study titled "Lamotrigine Bioequivalence". In this study, brand name lamotrigine (LAMICTAL) and generic lamotrigine will be compared in patients with epilepsy. Both the brand name and generic lamotrigine are approved by the Food and Drug Administration (FDA) and are commonly used to treat epilepsy. Some physicians and patients with epilepsy ...
What is the current status of trial NCT01995825?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 35 participants. The study started on 2012-05. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01995825?
The interventions under investigation include: Brand lamotrigine (DRUG), Generic lamotrigine (DRUG).
Who is sponsoring clinical trial NCT01995825?
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 NCT01995825's enrollment target sits among peer trials
35 1506th of 2000 higher than 481 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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