Early vigabatrin augmenting GABA-ergic pathways in post-anoxic status epilepticus (VIGAB-STAT) phase IIa clinical trial study protocol
Maciel CB, Teixeira FJP, Dickinson KJ, Spana JC, Merck LH, Rabinstein AA, Sergott R, Shan G, Miao G, Peloquin CA, Busl KM, Hirsch LJ. Early vigabatrin augmenting GABA-ergic pathways in post-anoxic status epilepticus (VIGAB-STAT) phase IIa clinical trial study protocol. Neurological Research And Practice 2022, 4: 4. PMID: 35067230, PMCID: PMC8785535, DOI: 10.1186/s42466-022-00168-x.Peer-Reviewed Original ResearchStatus epilepticusClinical trialsVigabatrin levelsClinical trial study protocolPost-cardiac arrest periodRefractory focal-onset seizuresDose-linear pharmacokineticsPrimary feasibility endpointBlinded outcome assessmentEffective adjunctive treatmentSingle loading doseTrial study protocolBrain GABA levelsCardiac arrest survivorsPilot clinical trialLast quantifiable concentrationFocal onset seizuresGABA-ergic pathwaysReports of survivorsConcentration-time curvePrimary pharmacokinetic endpointsFeasibility endpointsAggressive treatmentEligible subjectsNeuronal injury