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NCT02707965 · ClinicalTrials.gov registry record · Phase 1
Characterization of Epilepsy Patients BEEP 2b
A Phase 1 study, sponsored by Food and Drug Administration (FDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT02707965: Completed Phase 1 study, sponsored by Food and Drug Administration (FDA).
NCT02707965 is a Phase 1 study that has completed, run by Food and Drug Administration (FDA). The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02707965, a Phase 1 study, has completed, sponsored by Food and Drug Administration (FDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
Some epilepsy patients are described as GB when they have worsened seizures or side effects related to switching between brand name and generic, or between generic antiepileptic drug (AED) products. In concert with Aim 1 (protocol BEEP2a), this study will uncover possible reasons for patient problems with the drug switching. Factors that will be studied in GB epilepsy patients include physiologic, psychological, and genetic factors, including in this protocol whether brand and generic AEDs are pharmacokinetically similar in GB individuals.
Primary Outcome
Average AUC (area under the drug plasma curve.
Interventions
- DRUG Oxcarbazepine (brand name vs generic drugs)
- DRUG Divalproex Sodium (brand name vs generic drugs)
- DRUG Carbamazepine (brand name vs generic drugs)
- DRUG Lamotrigine (brand name vs generic drugs)
- DRUG levetiracetam (brand name vs generic drugs)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2017-06-08 |
| Est. Completion | 2018-09-04 |
| Phase | Phase 1 |
What the finished NCT02707965 record still lists
NCT02707965 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 5 interventions - of which Oxcarbazepine (brand name vs generic drugs) is the first listed.
NCT02707965 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02707965 about?
NCT02707965 is a clinical study titled "Characterization of Epilepsy Patients BEEP 2b". Some epilepsy patients are described as GB when they have worsened seizures or side effects related to switching between brand name and generic, or between generic antiepileptic drug (AED) products. In concert with Aim 1 (protocol BEEP2a), this study will uncover possible reasons for patient problem...
What is the current status of trial NCT02707965?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2017-06-08. Estimated completion is 2018-09-04.
What interventions are being tested in trial NCT02707965?
The interventions under investigation include: Oxcarbazepine (brand name vs generic drugs) (DRUG), Divalproex Sodium (brand name vs generic drugs) (DRUG), Carbamazepine (brand name vs generic drugs) (DRUG), Lamotrigine (brand name vs generic drugs) (DRUG), levetiracetam (brand name vs generic drugs) (DRUG).
Who is sponsoring clinical trial NCT02707965?
This trial is sponsored by Food and Drug Administration (FDA), which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02707965's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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