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NCT01713777 · ClinicalTrials.gov registry record · Phase 4
Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy: Chronic-Dose 4-Period Replicate Design
A Phase 4 study, sponsored by University of Cincinnati.
- Completed
- Registry status
- Phase 4
- Development phase
- 35
- Enrollment target
NCT01713777 is a Phase 4 study that has completed, run by University of Cincinnati. The registered enrollment target is 35 participants.
The verdict
NCT01713777, a Phase 4 study, has completed, sponsored by University of Cincinnati.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 35 participants
- Enrollment target
Study Summary
The United States Food and Drug Administration (FDA) has specific rules generic drug companies must follow to get a generic copy of a seizure medication approved. Currently, the 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. When the FDA tests generic copies of lamotrigine (LTG), the blood levels measured after volunteers receive the generic lamotrigine tablets are allowed to fall within a specific range. This research will test whether two different manufacturer's generic lamotrigine, that fall in different parts of that range, perform in a similar way when given to people with epilepsy every day over a several week period. The two products will be called GENERIC A and GENERIC B. The generic forms of the study drug lamotrigine to be tested in this study are approved by the FDA for the treatment of seizures.
Interventions
- DRUG Lamotrigine Generic "A"
- DRUG Lamotrigine generic "B"
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01713777
The ClinicalTrials.gov registry entry for NCT01713777 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 35 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 Generic "A" is the first listed.
NCT01713777 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01713777 about?
NCT01713777 is a clinical study titled "Equivalence Among Antiepileptic Drug Generic and Brand Products in People With Epilepsy: Chronic-Dose 4-Period Replicate Design". The United States Food and Drug Administration (FDA) has specific rules generic drug companies must follow to get a generic copy of a seizure medication approved. Currently, the FDA approves generic drugs by requiring studies on normal volunteers who don't have epilepsy and who take just one dose of...
What is the current status of trial NCT01713777?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 35 participants. The study started on 2013-04. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01713777?
The interventions under investigation include: Lamotrigine Generic "A" (DRUG), Lamotrigine generic "B" (DRUG).
Who is sponsoring clinical trial NCT01713777?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
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