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VALTOCO in Pediatric Subjects With Epilepsy
NCT05076838Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2021
- Primary completion
- Mar 2025
- Countries
- 1
- Sponsor
- Neurelis
- Modality
- Small Molecules
- Drugs
- diazepam nasal spray
- Conditions
- epilepsy
01
Overview
Phase 2, open-label, single-arm trial of diazepam nasal spray in epilepsy, sponsored by Neurelis. Primary endpoint: Maximum Plasma Concentration. Started Nov 2021; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Valtoco In Pediatric Subjects with Epilepsy
5 mg, 10 mg, or 15 mg dose of intranasal VALTOCO will be administered based on the subject's body weight.
03
Who it enrols
Pediatric patients aged 2 to 5 years with epilepsy weighing 6 to 33 kg, who may need benzodiazepine intervention for seizure control.
04
Endpoints
Primary
Maximum Plasma Concentration
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