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Safety of IV Lacosamide in Pediatric Epilepsy
NCT02710890Phase 3
Key facts
- Status
- Completed
- Start
- May 2017
- Primary completion
- Jun 2019
- Countries
- 5
- Sponsor
- UCB
- Modality
- Small Molecules
- Drugs
- lacosamide
- Conditions
- epilepsy
01
Overview
Phase 3, open-label, single-arm trial of lacosamide in epilepsy, sponsored by UCB. Primary endpoints: Percentage of Participants With at Least One Adverse Event at Day 37 and Percentage of Participants That Withdrew Due to Adverse Events at Day 37. Started May 2017; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Lacosamide
Intravenous Lacosamide (10 mg/ml)
03
Who it enrols
Pediatric patients (1 month to <17 years) with epilepsy, weighing >=4 kg. Must be candidates for IV infusion. Excludes patients with Dravet's syndrome, status epilepticus, significant heart disease, or creatinine clearance <30 mL/min.
04
Endpoints
Primary
Percentage of Participants With at Least One Adverse Event
Percentage of Participants That Withdrew Due to Adverse Events
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