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BEEP 2b: Brand vs Generic AEDs in Epilepsy
NCT02707965Phase 1Completed
- Sponsor
- Food and Drug Administration
- Start
- Jun 2017
- Primary completion
- Aug 2018
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Phase 1, randomised, double-blind trial of oxcarbazepine, divalproex sodium, carbamazepine, lamotrigine, levetiracetam and 3 more in epilepsy (2 arms), sponsored by Food and Drug Administration. Primary endpoints: Mean Area Under the Curve at Steady State at 24 hours, Mean Maximum Plasma Concentration at Steady State at 24 hours and 1 more. Started Jun 2017; status: completed.
02
Drugs
oxcarbazepinedivalproex sodiumcarbamazepinelamotriginelevetiracetam
03
Conditions
epilepsy
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