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Vanquix Auto-Injector for Acute Repetitive Seizures in Epilepsy
NCT00319501Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2006
- Primary completion
- Jul 2014
- Countries
- 1
- Sponsor
- Pfizer
- Modality
- Small Molecules, Device-based Delivery
- Drugs
- Vanquix
- Conditions
- epilepsyAcute repetitive seizures (ARS)
01
Overview
Phase 3, randomised, double-blind trial in epilepsy and Acute repetitive seizures (ARS) comparing Placebo with Vanquix (2 arms). Primary endpoints: Time to Next Seizure or Rescue Medication During the Double-blind Period at 12 hours and Percentage of Participants With an Event (Next Seizure or Rescue Medication) During the Open-label Period at 12 hours. Started Jan 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo
Placebo auto-injector
Vanquix
Diazepam auto-injector
03
Who it enrols
Patients older than 2 years with refractory epilepsy and acute repetitive seizures, on stable AEDs, with a responsible caregiver.
04
Endpoints
Primary
Time to Next Seizure or Rescue Medication During the Double-blind Period
Percentage of Participants With an Event (Next Seizure or Rescue Medication) During the Open-label Period
Secondary
Number of Participants Requiring Rescue Medication During the Double-blind Period
Number of Participants Requiring Emergency Department Visits During the Double-blind Period
Number of Participants Requiring Rescue Medical Care Other Than Rescue Medication or Emergency Department Visits During the Double-blind Period
Mean Score on Caregiver Global Treatment Assessment During the Double-blind Period
Mean Score on Physician Global Treatment Assessment During the Double-blind Period
Number of Participants Requiring Rescue Medication During the Open-label Period
Number of Participants Requiring Emergency Department Visits During the Open-label Period
Number of Participants Requiring Rescue Medical Care Other Than Medication or Emergency Department Visits During the Open-label Period
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