Ketamine and Levetiracetam as Second-line Antiseizure Medication for Status Epilepticus in Children
Recruiting
Phase 2
Phase 3
Interventional Study
Generalized Convulsive Status Epilepticus
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 – 16
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 124 (estimated)
- Sponsor
- Sohag University · Other
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About This Trial
About 40% of children with generalized convulsive status epilepticus (GCSE) are not terminated by first-line benzodiazepines (BDZs), and approximately 50% of BDZ-refractory GCSE are not controlled by second-line antiseizure medications. This study investigates the efficacy of ketamine-levetiracetam combination vs. levetiracetam alone for treating children with BDZ-refractory GCSE.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age from 1 year to 16 years.
* Generalized convulsive status epilepticus (GCSE), defined as clinically observed generalized tonic-clonic convulsions that continue or recur without complete regaining of consciousness in between for longer than 5 minutes.
* Benzodiazepine-refrac…
Contacts