2019
Deferoxamine mesylate in patients with intracerebral haemorrhage (i-DEF): a multicentre, randomised, placebo-controlled, double-blind phase 2 trial
Selim M, Foster L, Moy C, Xi G, Hill M, Morgenstern L, Greenberg S, James M, Singh V, Clark W, Norton C, Palesch Y, Yeatts S, Investigators I, Dolan M, Yeh E, Sheth K, Kunze K, Muehlschlegel S, Nieto I, Claassen J, Falo C, Huang D, Beckwith A, Messe S, Yates M, O'Phelan K, Escobar A, Becker K, Tanzi P, Gonzales N, Tremont C, Venkatasubramanian C, Thiessen R, Save S, Verrault S, Collard K, DeGeorgia M, Cwiklinski V, Thompson B, Wasilewski L, Andrews C, Burfeind R, Torbey M, Hamed M, Butcher K, Sivakumar L, Varelas N, Mays-Wilson K, Leira E, Olalde H, Silliman S, Calhoun R, Dangayach N, Renvill R, Malhotra R, Kordesch K, Lord A, Calahan T, Geocadin R, Parish M, Frey J, Harrigan M, Leifer D, Mathias R, Schneck M, Bernier T, Gonzales-Arias S, Elysee J, Lopez G, Volgi J, Brown R, Jasak S, Phillips S, Jarrett J, Gomes J, McBride M, Aldrich F, Aldrich C, Kornbluth J, Bettle M, Goldstein J, Tirrell G, Shaw Q, Jonczak K. Deferoxamine mesylate in patients with intracerebral haemorrhage (i-DEF): a multicentre, randomised, placebo-controlled, double-blind phase 2 trial. The Lancet Neurology 2019, 18: 428-438. PMID: 30898550, PMCID: PMC6494117, DOI: 10.1016/s1474-4422(19)30069-9.Peer-Reviewed Original ResearchConceptsBetter clinical outcomesPhase 2 trialSerious adverse eventsRankin Scale scorePlacebo groupIntracerebral hemorrhagePrimary outcomeClinical outcomesDay 90Deferoxamine mesylateModified intentionTreat populationAdverse eventsUS National InstitutesDouble-blind phase 2 trialScale scorePhase 3 efficacy trialsModified Rankin Scale scoreEfficacy of deferoxaminePhase 3 trialSupratentorial intracerebral hemorrhageAbsolute risk differenceProportion of participantsNational InstituteIron chelator deferoxamine
2016
Safety and efficacy of intravenous glyburide on brain swelling after large hemispheric infarction (GAMES-RP): a randomised, double-blind, placebo-controlled phase 2 trial
Sheth KN, Elm JJ, Molyneaux BJ, Hinson H, Beslow LA, Sze GK, Ostwaldt AC, del Zoppo GJ, Simard JM, Jacobson S, Kimberly WT. Safety and efficacy of intravenous glyburide on brain swelling after large hemispheric infarction (GAMES-RP): a randomised, double-blind, placebo-controlled phase 2 trial. The Lancet Neurology 2016, 15: 1160-1169. PMID: 27567243, DOI: 10.1016/s1474-4422(16)30196-x.Peer-Reviewed Original ResearchConceptsPlacebo-controlled phase 2 trialIntravenous glyburideLarge hemispheric infarctionPhase 2 trialGlyburide groupHemispheric infarctionDecompressive craniectomyPlacebo groupBrain swellingModified Rankin Scale scoreProtocol study populationWeb-based randomisationComposite primary outcomePrimary efficacy outcomeSerious adverse eventsProportion of patientsRankin Scale scoreBolus intravenous injectionLarge hemispheric strokePotential clinical benefitEfficacy outcomesStudy drugAdverse eventsCardiac eventsCerebral edema