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NCT01733394 · ClinicalTrials.gov registry record · Phase 4
Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy: Single-Dose 6-Period Replicate Design (EQUIGEN Single-Dose Study)
A Phase 4 study, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 4
- Development phase
- 54
- Enrollment target
NCT01733394 is a Phase 4 study that has completed, run by University of Cincinnati. The registered enrollment target is 54 participants.
The verdict
NCT01733394, a Phase 4 study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 54 participants
- Enrollment target
Study Summary
The United States Food and Drug Administration (FDA) has specific rules which generic drug companies must follow to get a generic copy of a seizure medication approved. Currently, FDA approves generic drugs by requiring studies on normal volunteers who don't have epilepsy and who take just one dose of the generic drug followed by a series of blood tests. Some people with epilepsy and their physicians have complained about side effects or loss of seizure control when taking generic drugs, but no one knows if these complaints are truly because of problems with the generic drugs. This research is to determine whether several different generic versions and the brand version of the medication lamotrigine perform in a similar way when given to people with epilepsy. The study drug Lamictal® (lamotrigine) and both of the generic forms of lamotrigine to be tested are approved by the FDA for the treatment of seizures.
Interventions
- DRUG lamotrigine
- DRUG Lamotrigine Generic "A" Lamotrigine Generic "B" Lamotrigine "Brand"
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2012-12-12 |
| Est. Completion | 2016-09-26 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01733394
The ClinicalTrials.gov registry entry for NCT01733394 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Cincinnati, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which lamotrigine is the first listed.
NCT01733394 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01733394 about?
NCT01733394 is a clinical study titled "Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy: Single-Dose 6-Period Replicate Design (EQUIGEN Single-Dose Study)". The United States Food and Drug Administration (FDA) has specific rules which generic drug companies must follow to get a generic copy of a seizure medication approved. Currently, FDA approves generic drugs by requiring studies on normal volunteers who don't have epilepsy and who take just one dose ...
What is the current status of trial NCT01733394?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 54 participants. The study started on 2012-12-12. Estimated completion is 2016-09-26.
What interventions are being tested in trial NCT01733394?
The interventions under investigation include: lamotrigine (DRUG), Lamotrigine Generic "A" Lamotrigine Generic "B" Lamotrigine "Brand" (DRUG).
Who is sponsoring clinical trial NCT01733394?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
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