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Padsevonil Open-Label Extension in Drug-Resistant Epilepsy
NCT03370120Phase 2
Key facts
- Status
- Terminated
- Start
- Aug 2018
- Primary completion
- Dec 2020
- Countries
- 27
- Sponsor
- UCB
- Modality
- Small Molecules
- Drugs
- padsevonil
- Conditions
- epilepsy
01
Overview
Phase 2, open-label, single-arm trial of padsevonil in epilepsy, sponsored by UCB. Primary endpoints: Percentage of Participants With Treatment-Emergent Adverse Events at 2 years, Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Withdrawal at 2 years and 1 more. Started Aug 2018; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Padsevonil Extension
Continued treatment with Padsevonil at individualized doses
03
Who it enrols
Adults (18+) with drug-resistant epilepsy who completed a parent Padsevonil study (EP0091 or EP0092). Excludes severe medical/psychiatric conditions, active suicidal ideation, significant liver enzyme elevations (>2x ULN), or clinically significant ECG/echocardiogram abnormalities.
04
Endpoints
Primary
Percentage of Participants With Treatment-Emergent Adverse Events
Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Withdrawal
Change From Baseline in Observable Focal-onset Seizure Frequency
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