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Safety and Efficacy of Eslicarbazepine Acetate in Refractory Partial Seizures
NCT02170077Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2002
- Primary completion
- Nov 2002
- Countries
- 1
- Sponsor
- BIAL
- Modality
- Small Molecules
- Conditions
- epilepsy
01
Overview
Phase 2, randomised, double-blind trial of eslicarbazepine acetate in epilepsy (3 arms), sponsored by BIAL. Primary endpoint: Percentage of Participants With a 50% or Greater Reduction in Seizure Frequency at 12 weeks. Started Apr 2002; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Once-daily group
BIA 2-093 once-daily (400mg -> 800mg -> 1200mg)
Twice-daily group
BIA 2-093 twice-daily (400mg -> 800mg -> 1200mg total daily)
Placebo group
Placebo
03
Who it enrols
Adult patients (18-65) with refractory simple or complex partial seizures (>=4/month) on a stable regimen of 1-2 AEDs (excluding oxcarbazepine/carbamazepine).
04
Endpoints
Primary
Percentage of Participants With a 50% or Greater Reduction in Seizure Frequency
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